Peginterferon lambda 1a - Eiger BioPharmaceuticals/ZymoGenetics
Alternative Names: BMS-914143; Lambda - Eiger BioPharmaceuticals; PEG-IL-29 - ZymoGenetics; PEG-interferon lambda; PEG-interleukin-29 - ZymoGenetics; PEG-rIL-29 - ZymoGenetics; Peginterferon lambda-1a - Eiger BioPharmaceuticals/ZymoGenetics; Pegylated interferon lambda - Eiger BioPharmaceuticalsLatest Information Update: 11 Apr 2024
At a glance
- Originator ZymoGenetics
- Developer Bristol-Myers Squibb; Eiger BioPharmaceuticals, Inc.; University Health Network; ZymoGenetics
- Class Antivirals; Interferons; Interleukins
- Mechanism of Action Interleukin 29 receptor agonists
-
Orphan Drug Status
Yes - Hepatitis D
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase III COVID 2019 infections; Hepatitis D
- No development reported Multiple sclerosis
- Discontinued Cancer; Hepatitis B; Hepatitis C
Most Recent Events
- 31 Dec 2023 Eiger BioPharmaceuticals has patent protection for peginterferon lambda 1a in USA and Europe
- 31 Dec 2023 Eiger BioPharmaceuticals has patents pending for peginterferon lambda 1a in multiple countries worldwide
- 31 Dec 2023 Eiger Biopharmaceuticals plans to file BLA for Peginterferon lambda 1a for COVID-2019 infections and Hepatitis D
Development Overview
Introduction
Peginterferon λ-1a (PEG-IFN-λ or PEG-IL-29) is being developed by Eiger Biopharmaceuticals as a first in class interferon, for the treatment of hepatitis D virus (HDV) infections and COVID-2019 infections. The therapy was originally developed by ZymoGenetics, and subsequently licensed to Eiger Biopharmaceuticals. Interleukin-29 (IL-29) is a member of the type III interferon family and is generated by the immune system in response to viral infection, and act as the initial line of defense to limit virus spread at the epithelial barrier without triggering inflammation. Peginterferon λ-1a is considered to be an effective antiviral agent with an improved safety profile over currently available therapies. It targets type III interferon receptors, which are distinct from type I interferon receptors targeted by interferon alfa. The interferon lambdas are critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden before type I IFNs to limit the initial infection by inducing viral resistance to cells and enable them deal with the virus load. The type III receptors demonstrate limited expression on haematopoietic and CNS cells, thereby reducing the potential for off-target effects. Clinical development for hepatitis D virus infections is underway in several countries. Clinical development for COVID-2019 infections is underway in the US, Brazil and Canada.
Bristol-Myers Squibb terminated its phase III development for peginterferon λ-1a for the treatment of hepatitis C, after assessments of the commercial viability of products that indicated lower likelihood of registration due to global introduction of oral non-interferon products for the treatment of HCV. Previously, phase III development in patients with hepatitis C virus infection was conducted globally, and phase III development for the treatment of hepatitis B, was conducted in the US, Canada, Australia, the EU, Hong Kong, South Korea, Singapore and Taiwan. However, preclinical development of the product was discontinued for cancer, and no recent reports of development were identified for multiple sclerosis in the US.
As of June 2023, Eiger is evaluating strategic partnering options for its virology assets, lonafarnib and peginterferon lambda [1] .
Company Agreements
In April 2016, Eiger Biopharmaceuticals obtained exclusive worldwide license from Bristol Meyers Squibb (BMS), for the development of peginterferon lambda-1a, as investigational therapy for hepatitis delta virus infection. The worldwide license from Bristol Mayers Squibb led to an upfront payment and issuance of Eiger common stock, payment on achievement of regulatory and development milestones on achievement of target commercial sales in the US, European Union countries and Japan and tiered annual royalties on net sales. In April 2016, Eiger Biopharmaceuticals paid an upfront payment of $US2 million in cash and issued shares of its common stock with an aggregate value of $3.2 million to BMS. Eiger Biopharmaceuticals will make development and regulatory milestone payments totaling $US61 million and commercial sales milestones of up to $US128 million after the achievement of specified milestones. [2] [3]
In October 2010, ZymoGenetics was acquired by Bristol-Myers Squibb [4] . Prior to the acquisition, Bristol-Myers Squibb and ZymoGenetics were involved in a global collaboration for peginterferon λ-1a [5] [6] .
Novo Nordisk had previously licensed exclusive development rights from ZymoGenetics outside North America to patents covering peginterferon λ-1a. Under the terms of the agreements, Novo Nordisk was to pay ZymoGenetics initial licence fees along with potential milestone and royalty payments. Other financial details of the transactions were not disclosed [7] . However, this agreement is no longer active.
Key Development Milestones
As of December 2023, Eiger Biopharmaceuticals has announced an intention to file BLA for Peginterferon lambda 1a for COVID-2019 infections and Hepatitis D [8] .
COVID-2019 infections
In May 2021, Eiger BioPharmaceuticals announced that IND application for peginterferon lambda-1a is open and includes phase II/III protocol. Earlier in February 2021, company announced finalising the FDA regulatory guidance on a potential phase II/III registration-enabling study of Lambda in COVID-19 [9] [10] .
In August 2021, University Health Network in collaboration with Eiger BioPharmaceuticals initiated the phase III TOGETHER-Toronto trial to evaluate the effect of peginterferon lambda for the treatment of COVID-19 infections (NCT04967430; JF-12-2020). The randomised, double-blind study intends to enrol 763 patients in Canada [11] .
In January 2021, Cardresearch, in collaboration with Eiger BioPharmaceuticals initiated a phase III TOGETHER trial to evaluate the effect of fluvoxamine, ivermectin, doxasozin and peginterferon lambda 1a in reducing hospitalisation of patients with mild COVID-19 and a high risk of complications (NCT04727424; TOGETHER_2) [12] . The randomised, double blind study intends to enrol approximately 6246 patients in Brazil. As of March 2022, the trial completed enrolment of more than 1,800 patients in Brazil [13] [14] [10] . In July 2021, first participant was dosed [15] [16] . In September 2021, the Data Safety Monitoring Board (DSMB) recommended that investigators continue enrolment of the peginterferon lambda arm in the platform study [17] . In November 2021, company reported that data from this study could support emergency use authorization package [18] . In December 2021, Eiger BioPharmaceuticals announced that the trial has conducted second interim futility analysis and recommended continuation of dosing of peginterferon lambda in the trial [19] . In March 2022, Eiger BioPharmaceuticals released final efficacy and safety results from the trial. In October 2022, US FDA denied the request for a pre-EUA meeting based on the data which is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic and now the company has no further plan to submit EUA application [20] [21] [22] . In February 2023, safety and efficacy data were released by Eiger BioPharmaceuticals [11] .
Icahn School of Medicine at Mount Sinai and Eiger BioPharmaceuticals, due to the number of competing trials at their site, closed and withdrew a phase II study, that was designed to evaluate the safety and efficacy of peginterferon lambda-1a for the treatment of COVID-2019 infections (NCT04388709; GCO 20-0820). The study was planned to be conducted in the US [23] .
In October 2021, Eiger BioPharmaceuticals in a collaboration with Massachusetts General Hospital terminated a phase II trial due to lack of funding and trial unbale to meet enrolment goal. The trial was initiated to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs. placebo in up to 20 in patients with COVID-19 infection (NCT04343976; 2020P001083). The randomised trial enrolled 14 patients in the US [24] .
In September 2021, Johns Hopkins University and Eiger BioPharmaceuticals terminated the phase II PROTECT trial, for prevention of SARS-CoV-2 infection in non-hospitalised participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19), due to low enrolment (IRB00248163; NCT04344600). The randomised, single blinded trial initiated in June 2020, enrolled six participants in the US [25] .
In 2020, University Health Network completed the phase II ILIAD trial that evaluated effect of subcutaneous peginterferon lambda-1a for the Treatment of COVID-2019 infections (NCT04354259; JF-4-2020). The investigator sponsored, randomised, quadruple blind trial was initiated in May 2020 and enrolled 157 patients in Canada and Brazil [26] [27] . In October 2020, Eiger BioPharmaceuticals released efficacy and safety data from the trial [28] . In February 2021, company released final results from the trial [9] .
In May 2021, Stanford University completed a phase II trial that evaluated the efficacy of a single subcutaneous dose (180ug) of peginterferon lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-2019 infections (55619; NCT04331899). The randomised, single blind trial was initiated in April 2020, and enrolled 120 patients in the US. The trial completed enrolment of 120 patients in the US, in September 2020 [29] [30] . The company released safety and efficacy data from the trial, in September 2020 [31] .
As of August 2020, Eiger BioPharmaceuticals announced that six international investigator sponsored studies were in progress for peginterferon lambda in COVID-19 [32] .
As of April 2020, peginterferon lambda-1a showed a potent antiviral effects against influenza, COVID-2019 infections, rotavirus, norovirus, and reovirus. The company also announced that it is assisting in the protocol design of multiple investigator-sponsored studies that are being initiated to evaluate the safety and efficacy of peginterferon lambda-1a in patients diagnosed with COVID-2019 infections [33] .
Hepatitis D infections
In August 2019, Eiger BioPharmaceuticals announced that peginterferon lambda-1a was granted Breakthrough Therapy Designation by the US FDA for the treatment of hepatitis delta virus (HDV) infection and orphan drug designation by the European Medicines Agency [34] . In September 2017, the US FDA granted orphan drug status to peginterferon lambda-1a for the treatment of chronic hepatitis delta virus (HDV) infections [35] .
In September 2023, Eiger BioPharmaceuticals discontinued the pivotal phase III LIMT-2 study, based on recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review which observed four patients with hepatobiliary events that resulted in liver decompensation [36] . The trial evaluated the efficacy and safety of 180 mcg peginterferon lambda-1a subcutaneous injection for 48 weeks in patients with chronic hepatitis delta virus (HDV) infection (LIMT-2) (EIG-LMD-002; NCT05070364) [18] . The randomized, open-label, parallel, two-arm trial, initiated in December 2021, enrolled 158 patients in the US, Belgium, Bulgaria, France, Georgia, Germany, Israel, Italy, Moldova, Romania, Spain and Turkey. In same month, Eiger BioPharmaceuticals announced that the first patient has been enrolled in the global phase III LIMT-2 study of 48-week treatment with Peginterferon Lambda in patients with chronic hepatitis delta virus (HDV) infection [37] [13] . Before August 2020, Eiger BioPharmaceuticals had reached single, pivotal phase III LIMT-2 study design agreement with FDA and EMA of peginterferon lambda-1a monotherapy for the treatment of hepatitis delta virus infections [32] [38] [39] . The primary endpoint is a durable virologic response (DVR), or HDV RNA below limit of quantitation (BLQ) or undetectable, 24-weeks post treatment of arm 1 compared to placebo after 12-weeks of no treatment of arm 2 [3] . In December 2019, Eiger BioPharmaceuticals completed an end of phase II meeting with the US FDA for a pivotal phase III study. Eiger intends to finalize scientific advice with EMA and the global development plan for lambda in 2020 [40] . In June 2019, Eiger BioPharmaceuticals reported of its intention to conduct an end of phase II meeting, for discussions regarding development in Hepatitis D [41] .
In November 2020, National Institute of Diabetes and Digestive and Kidney Diseases and Eiger BioPharmaceuticals completed the phase II LIFT (Lambda InterFeron combo-Therapy) trial designed to evaluate the combination of peginterferon lambda-1a, lonafarnib [see AdisInsight drug profile 800009901] and ritonavir [see AdisInsight drug profile 800004117] in HDV-infected patients (NCT03600714;18-DK-0123). The open-label trial initiated in May 2018, enrolled 26 patients in the US. In March 2018, reported that the company had a face-to-face interaction with the US FDA, in February 2018, regarding hepatitis D programme following which the trial was initiated [42] [43] [44] [45] . In October 2019, Eiger BioPharmaceuticals released 24 week interim safety and efficacy results from the trial [46] . Safety and efficacy data from this study was presented at The International Liver Congress 2020 (ILC-2020) [47] . In November 2020, Eiger BioPharmaceuticals presented final results from the trial at The Liver Meeting Digital Experience™ 2020 (LMDE-2020) [48] .
In July 2017, the US FDA granted fast track designation to peginterferon λ-1a for the treatment of hepatitis D virus infections [49] . In May 2017, Eiger BioPharmaceuticals reported the filing and approval of an IND application with the US FDA, for peginterferon lambda-1a for the treatment of hepatitis D virus infections [50] . The company intends to expand the ongoing LIMT HDV study [see below] to sites in the US [51] .
In November 2023, pooled analysis of efficacy data from phase II LIMT-1 and LIFT-1 (see below) trials were presented at 74th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2023) [52]
In December 2018, Eiger BioPharmaceuticals completed the phase II LIMT HDV (Lambda Interferon MonoTherapy in HDV) trial that assessed the pharmacodynamics, safety and tolerability of peginterferon lambda-1a (120μg and 180μg) once weekly SC injection in patients with hepatitis D virus infection (LIMT-1; EIG-LMD-001; NCT02765802). The 48-week, open-label, parallel, randomised trial was initiated in August 2016 and enrolled 33 patients in New Zealand, Israel and Pakistan [53] [51] [54] [55] . Interim results of the trial were released by the company [56] . In October 2017, the company presented at the the Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2017) [57] . Eiger announced the completion of doing in August 2018 [58] . Positive week 48 results from the trial were released by Eiger BioPharmaceuticals in October 2018 [59] . In April 2019, Eiger BioPharmaceuticals released 48 and 72 week safety and efficacy results from the trial [60] . In November 2020, the company released updated results of the study [61] .
Bristol-Myers Squibb terminated its phase III development for peginterferon λ-1a for the treatment of hepatitis C during 2014. The decision was taken after assessments of the commercial viability of the product that showed the lower likelihood for filing for registration in certain markets due to global introduction of oral non-interferon products for the treatment of HCV.
Hepatitis C infections
In October 2014, a phase III STRUCTURE trial that was completed by Bristol-Myers Squibb (BMS) evaluated peginterferon λ-1a in combination with daclatasvir and ribavirin, or telaprevir in combination with peginterferon-α-2a and ribavirin in patients with chronic hepatitis C genotype 1b, who were treatment naive or previous relapsers to therapy with peginterferon-α-2a and ribavirin (NCT01718158; EudraCT2011-005409-65). The trial enrolled is 444 patients in the US, Argentina, France, Germany, Israel, Italy, Japan, South Korea, Poland, Russia, Spain, Taiwan and the UK [62] .
In January 2015, Bristol-Myers Squibb completed a phase III trial that evaluated the safety and efficacy of combination of pegylated-interferon λ-1a, ribavarin and daclatasvir in patients with chronic hepatitis C infection and underlying haemophilia who were treatment naive or who were prior relapsers to peginterferon-α-2a and ribavirin therapy (MAGNITUDE; NCT01741545; EudraCT2012-003463-22). The primary endpoint is proportion of patients who achieve SVR12, assessed at 12 weeks. The non-randomised, open-label trial enrolled 51 patients in the US, Australia, France, Italy, the Netherlands, Romania, Russia and Spain [63] .
In May 2015, Bristol-Myers Squibb completed a multinational phase III trial that assessed the efficacy and safety of peginterferon λ-1a compared with peginterferon-α-2a in patients with chronic hepatitis C; all patients received concomitant ribavirin and telaprevir (NCT01598090; EudraCT2011-004695-11; 15564; AI452-020; CCRN2684; PEDESTAL). Participants will be treatment-naive or relapsed on prior treatment with peginterferon-α-2a and ribavirin. The randomised, double-blind trial was initiated in June 2012, that enrolled 646 patients in the US, UK, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, the Netherlands, Poland, Russia, Spain, and Switzerland [64] .
Bristol-Myers Squibb completed a phase III trial in November 2014, to investigate peginterferon λ-1a in patients with hepatitis C (NCT01525810; EudraCT2011-005293-31). This three-year follow-up trial was initiated in March 2012 and enrolled 218 patients in the US, Australia, Austria, Canada, France, Germany, Italy, New Zealand, Poland, Puerto Rico, Romania, Spain, Belgium, Finland, Greece, South Korea, Mexico, the Netherlands and Argentina [65] .
The phase III PRINCIPAL trial that compared the efficacy, tolerability and pharmacodynamics of peginterferon λ-1a + ribavirin, with and without daclatasvir, with peginterferon-α-2a + ribavirin, in patients with chronic, genotype 2 or 3 hepatitis C, was completed in September 2014 (AI452-017; NCT01616524; EudraCT2011-004885-14). The trial enrolled 880 patients in the US, Argentina, Australia, Belgium, Chile, Finland, France, Greece, Hong Kong Italy, Japan, South Korea, Mexico, Netherlands, New Zealand, Russia, Singapore, Taiwan and the UK [66] .
The phase III BASIS trial was initiated by Bristol-Myers-Squibb in March 2013 to evaluate the tolerability and efficacy of peginterferon λ-1a compared with peginterferon-α-2a, both in combination with ribavirin, in treatment-naïve patients with genotype 1 hepatitis C (NCT01754974; EudraCT2012-003508-11). The double-blind, randomised trial was designed to enrol approximately 40 patients in Czech Republic, Mexico, Poland and South Korea; however in July 2014, patient recruitment was suspended. As of November 2014, the trial registry mentions the trial to be completed [67] .
In August 2015, Bristol-Myers Squibb terminated phase-III DIMENSION trial due to sponsor decision not based on any new unexpected safety findings or efficacy observations (NCT01866930; EudraCT2012-003280-22), the trial aimed to assess the efficacy and safety of peginterferon λ-1a + ribavirin + daclatasvir in treatment-naive patients with hepatitis C infection of genotypes 1, 2, 3 or 4, co-infected with HIV. The open-label, non-randomised trial initiated in July 2013 and enrolled 453 patients in Argentina, Belgium, Canada, the UK, France, Germany, Italy, Mexico, Poland, Russia, Spain, and the US [68] .
Previously, Bristol-Myers Squibb was planning another global phase III trial to investigate the safety and efficacy of peginterferon λ-1a with ribavirin, compared with pegylated interferon-α-2a with ribavirin, in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (genotypes 1 or 4) (NCT01447394). However, this trial was withdrawn prior to recruitment [69] .
In October 2009, ZymoGenetics and Bristol-Myers Squibb initiated the phase II EMERGE trial to assess the safety and antiviral efficacy of peginterferon λ-1a in treatment-naïve patients with chronic HCV infection (NCT01001754; EudraCT2009-011786-80). The trial comprised two parts in approximately 55 and 600 patients in the first open-label part and second randomised, blinded part, respectively. Patients received subcutaneous injections of peginterferon λ-1a (120µg, 180µg or 240µg) or peginterferon-α-2a in combination with ribavirin for up to 48 weeks. The primary outcome measure was the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of treatment. The trial was conducted in the US, Canada, Puerto Rico, the EU and Australia. As of April 2011, all patients receiving peginterferon λ-1a 240µg were switched to peginterferon λ-1a 180µg (the dose selected for further development). Patient enrolment was completed in December 2011 [70] . Dosing of the first patient triggered a milestone payment of $US70 million to ZymoGenetics from Bristol-Myers Squibb [71] . The second (phase IIb) part of the EMERGE trial was initiated in June 2010 [72] [73] . Results were reported in April 2011, April 2012 and December 2012 [74] [75] [76] .
In September 2014, Bristol-Myers Squibb completed a 24-week, two-part, phase II trial of peginterferon λ-1a in combination with other antiviral agents in treatment-naïve patients with chronic hepatitis C genotype 1 infections (NCT01309932; D-LITE; EudraCT2010-022568-11). Part A of the trial investigated peginterferon λ-1a in combination with ribavirin plus a single direct antiviral agent daclatasvir [see RDI profile 800027519] or asunaprevir [see RDI profile 800027520] compared with peginterferon-α-2a in combination with ribavirin. Part B investigated peginterferon λ-1a administered with or without ribavirin plus daclatasvir and asunaprevir. The trial enrolled 165 patients with chronic HCV infection in the EU, the US, Australia, Japan, New Zealand and Puerto Rico [77] . Positive interim results were reported at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2012) [74] . A third part (part C) of the D-LITE trial is underway to assess the efficacy and tolerability of peginterferon λ-1a in combination with ribavirin plus daclatasvir in patients with genotype 1b chronic hepatitis C infections (NCT01795911). Enrolment of 20 patients has been completed in the US and the EU [78] .
A phase Ib study was initiated in December 2007 and completed in October 2009. The open label study enrolled 56 patients with HCV infection who had relapsed following prior treatment with peginterferon-α and ribavirin. Subcutaneous peginterferon λ-1a was administered alone and in combination with ribavirin (NCT00565539) [79] . Final results were reported at the annual meeting of the American Association for the Study of Liver Diseases (AASLD-2009) [80] [81] [82] [83] .
ZymoGenetics has completed a phase Ia trial with peginterferon λ-1a in healthy volunteers. Peginterferon λ-1a was well tolerated and had a pharmacokinetic profile which supported weekly dosing [84] [85] .
In vitro
antiviral activity against several viruses, including HCV, has been demonstrated with peginterferon λ-1a [86] . Peginterferon λ-1a has demonstrated antiviral activity against human HCV in the sub-genomic HCV replicon model. In addition, it induced antiviral gene expression similar to interferon in primary human hepatocytes.
Hepatitis B infections
In December 2013, Bristol-Myers Squibb completed a phase II trial, which assessed the safety, tolerability and efficacy of peginterferon λ-1a versus peginterferon α-2a monotherapy, in interferon-naive, HBeAg-positive patients with chronic hepatitis B virus infection (LIRA-B; NCT01204762; EudraCT2010-020387-38). The 48-week trial enrolled 163 patients in the US, Canada, Australia, the EU, Hong Kong, South Korea, Singapore and Taiwan [87] .
Phase I trials
a phase I clinical trial compared the pharmacokinetics of peginterferon λ-1a in healthy volunteers and patients with mild, moderate, severe or end-stage renal dysfunction (NCT01708889). A total of 43 participants were recruited in the US [88] .
Other indications
peginterferon λ-1a was in preclinical development for the treatment of multiple sclerosis in the US; however, no recent activity has been reported.
Peginterferon λ-1a was being investigated in preclinical trials for the treatment of cancer; however, it appears that the development for this indication has ceased.
Financing information
In January 2017, Eiger BioPharmaceuticals completed a debt financing transaction of $US25 million. The proceeds of the finances will be used for the development of company's pipeline including its lead programme for hepatitis delta virus infection. The financing is two-part transaction comprising of an initial $US15 million tranche drawn on 30th December 2016 and a second $US10 million tranche to be drawn at Eiger's discretion based on the achievement of pre-defined developmental milestones with initial payments by Eiger consisting of interest-only payments for 18 months through second quarter of 2018 [89] .
In August 2016, Eiger BioPharmaceuticals announced that it intends to offer and sell shares of its common stock in an underwritten public offering. The company plans to use the expected $US20 million in net proceeds of the offering to fund the clinical development of peginterferon lambda 1a, exendin 9 [see Adis Insight Drug profile 800043819], ubenimex [see Adis Insight Drug profile 800001888] and lonafarnib [see Adis Insight Drug profile 800009901] [90] [91] .
Patent Information
As of December 2023, Eiger BioPharmaceuticals announced that USPTO and the European Patent Office granted patent No. US1 095 307 2B2 for the use of interferon lambda for HDV treatment in the US and Europe. The patent covers the use of lambda for HDV treatment, with a term of at least 2037. Additional claims are being pursued in continuation/divisional applications in the US and Europe, with applications pending in China, Japan, and Korea. Eiger BioPharmaceuticals has also filed a PCT application for lambda in HDV. Additionally, Eiger BioPharmaceuticals has filed a PCT application for lambda and lonafarnib and ritonavir for HDV treatment, with patents expected to offer protection until 2040 [8] [92]
Zymogenetics owns an issued patent for IFN-λ1 polynucleotides, expression vectors, cells and methods of producing peginterferon λ-1a. The company has filed patent applications for peginterferon λ-1a polypeptides, peginterferon λ-1a fusion proteins, antibodies, and methods of expressing and purifying peginterferon λ-1a, methods of using peginterferon λ-1a alone and in combination with other therapeutic agents to treat various viral diseases, cancers and autoimmune disorders. The first expiration date of these patents is September 2021.
Eiger BioPharmaceuticals have in-licensed from Bristol-Myers Squibb a patent portfolio, covering manufacture, use, and compositions of peginterferon lambda. The composition of matter US patent will expire 2025 [93] .
Drug Properties & Chemical Synopsis
- Route of administration Parenteral, SC
- Formulation Injection, unspecified
- Class Antivirals, Interferons, Interleukins
- Target Interleukin 29 receptor
- Mechanism of Action Interleukin 29 receptor agonists
-
WHO ATC code
J05 (Antivirals for Systemic Use)
L03A-C (Interleukins)
N07 (Other Nervous System Drugs)
-
EPhMRA code
J5 (Antivirals for Systemic Use)
J5B1 (Viral hepatitis products)
L3 (Immunostimulating Agents)
L3B (Interferons)
N7 (Other CNS Drugs)
- Chemical name Pegylated interferon lambda-1; pegylated interleukin 29; N-{3-[α-methylpoly(oxyethylene)oxy]propyl}-L-methionyl{[171- serine]human interleukin-29 (IFN-λ-1)-(7-181)-peptide}
- Molecular formula C875 H1408 N254 O251 S5 (C2 H4 O)n
- CAS Registry Number 914617-98-4
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
COVID 2019 infections |
Eligibility Criteria |
T-cell surface antigen CD4 Ferritin C-reactive protein (CRP) |
|
|
COVID 2019 infections |
Outcome Measure |
IFNL4 Ferritin D-dimer Creatine Cardiac Troponin I C-reactive protein (CRP) |
|
|
hepatitis C |
Arm Group Label |
IFN-alpha 2 |
|
|
hepatitis C |
Outcome Measure |
Tubulin beta class IVb T-cell surface antigen CD4 Interferon Gamma (IFNg) Interferon alpha (IFN-alpha) IL28B hENT1 Beta-2-microglobulin (B2M) |
|
|
hepatitis C |
Detailed Description |
IFN-alpha 2 |
|
|
hepatitis C |
Eligibility Criteria |
T-cell surface antigen CD4 |
|
|
hepatitis C |
Official Title |
IFN-alpha 2 |
|
|
hepatitis D |
Eligibility Criteria |
Thyroid stimulating hormone beta (TSH) Alpha-fetoprotein (AFP) |
|
|
hepatitis D |
Official Title |
long intergenic non-protein coding RNA 1089 |
|
|
SARS-CoV-2 acute respiratory disease |
Eligibility Criteria |
Interleukin-6 (IL-6) interleukin 6 receptor C-reactive protein (CRP) |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Peginterferon lambda 1a - Eiger BioPharmaceuticals/ZymoGenetics | Alpha-fetoprotein (AFP) | Eligibility Criteria |
| C-reactive protein (CRP) | Eligibility Criteria, Outcome Measure | |
| Cardiac Troponin I | Outcome Measure | |
| Creatine | Outcome Measure | |
| D-dimer | Outcome Measure | |
| Ferritin | Eligibility Criteria, Outcome Measure | |
| hENT1 | Outcome Measure | |
| IFN-alpha 2 | Arm Group Label, Official Title | |
| IFNL4 | Outcome Measure | |
| IL28B | Outcome Measure | |
| Interferon alpha (IFN-alpha) | Outcome Measure | |
| Interferon Gamma (IFNg) | Outcome Measure | |
| long intergenic non-protein coding RNA 1089 | Official Title | |
| T-cell surface antigen CD4 | Eligibility Criteria, Outcome Measure | |
| Thyroid stimulating hormone beta (TSH) | Eligibility Criteria |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Newly diagnosed | Phase III | Canada | SC / Injection | Eiger BioPharmaceuticals, Inc., University Health Network | 27 Aug 2021 |
| COVID 2019 infections | early onset disease | Newly diagnosed | Phase III | Brazil | SC / Injection | Eiger BioPharmaceuticals, Inc. | 19 Jan 2021 |
| COVID 2019 infections | - | - | Phase II | USA | SC / Injection | Eiger BioPharmaceuticals, Inc. | 24 Apr 2020 |
| COVID 2019 infections | - | Prevention | Phase II | USA | SC / Injection | Eiger BioPharmaceuticals, Inc. | 29 May 2020 |
| Cancer | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | ZymoGenetics | 31 Dec 2008 |
| Hepatitis B | - | Treatment-naive | Discontinued (II) | Australia, Canada, France, Germany, Hong Kong, Netherlands, Singapore, Taiwan, USA | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | - | Combination therapy, Treatment-experienced, Treatment-naive | Discontinued (III) | Australia, France, Italy, Netherlands, Romania | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | Co-infection with HIV | Combination therapy | Discontinued (III) | Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, Poland, Russia, Spain, Switzerland, USA, United Kingdom | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | - | - | Discontinued (III) | Argentina, Belgium, Finland, Greece, Mexico, Netherlands, South Korea | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | Co-infection with HIV | Combination therapy, Treatment-naive | Discontinued (III) | Argentina, Australia, Chile, Finland, Greece, Hong Kong, Israel, Japan, Mexico, Netherlands, Russia, Singapore, South Korea, Taiwan, USA | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | - | Combination therapy, Treatment-naive | Discontinued (II/III) | New Zealand | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | - | Combination therapy, Treatment-naive | Discontinued (II) | Germany | SC / Injection | Bristol-Myers Squibb | 31 Dec 2014 |
| Hepatitis C | - | Combination therapy, Treatment-naive | Discontinued (II) | Puerto Rico | SC / Injection | Bristol-Myers Squibb, ZymoGenetics | 31 Dec 2014 |
| Hepatitis D | - | - | Phase III | Belgium, Bulgaria, France, Georgia, Germany, Israel, Italy, Moldova, Romania, Spain, Turkey, USA | SC / Injection | Eiger BioPharmaceuticals, Inc. | 23 Dec 2021 |
| Hepatitis D | - | Combination therapy | Phase II | USA (fast track) | SC / Injection | Eiger BioPharmaceuticals, Inc. | 11 May 2018 |
| Hepatitis D | - | - | Phase II | New Zealand, Pakistan | SC / Injection | Eiger BioPharmaceuticals, Inc. | 03 May 2017 |
| Multiple sclerosis | - | - | No development reported (Preclinical) | USA | Parenteral / unspecified | ZymoGenetics | 31 Dec 2010 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Hepatitis D |
| Breakthrough Therapy | USA | Hepatitis D |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Hepatitis D | - | European Union | Eiger BioPharmaceuticals, Inc. | 20 Aug 2019 |
| Hepatitis D | - | USA | Eiger BioPharmaceuticals, Inc. | 05 Sep 2017 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| ZymoGenetics | Originator | USA |
| ZymoGenetics | Owner | USA |
| Bristol-Myers Squibb | Licensee | World |
| Eiger BioPharmaceuticals, Inc. | Sub-licensee | World |
| University Health Network | Collaborator | Canada |
| Stanford University | Collaborator | USA |
| National Institute of Diabetes and Digestive and Kidney Diseases | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Eiger BioPharmaceuticals, Inc. | - | Unspecified | - | 29 Jun 2023 |
Credit Suisse Market Status
| Indication | Region | Company | Phase | Expected Launch Year | Probability of Success% | Patent Expiry Year | Expected Generic Entry | Last Update |
|---|---|---|---|---|---|---|---|---|
| HBV | Wrld (50% US) | - | Development Stopped | - | - | - | - | 05 Nov 2023 |
| Hepatitis C | Wrld (50% US) | - | Development Stopped | - | - | - | - | 05 Nov 2023 |
Scientific Summary
-
Adverse Events
Occasional:
Elevated aminotransferase levels; Fatigue; Flu-like symptoms; Musculoskeletal disorders; Nausea
Pharmacokinetics
Subcutaneously administered PEG-interleukin-29 showed detectable serum levels at 1 week at doses ≥1.5 µg/kg in a dose-ranging phase Ib study in HCV genotype 1 patients. The average Tmax value was approximately 24h (4-78h range). Cmax and AUC0-t values increased dose-proportionally with median AUC0-t ranging from 10.5 h ng mL-1 at the 0.5 µg/kg dose to 116 h ng mL-1 at the 3.0 µg/kg dose. The median accumulation index based on week 4 AUC0-t was 1.44. Median accumulation indices based on trough values ranged from 1.00 to 1.10 [97] .
After subcutaneous administration, exposure to PEG-interleukin-29 was dose-proportional, and the estimated half life was between 50 and 70 hours. The Tmax value was 8 to 24 hours [84] .
Adverse Events
Phase II
interim results of the phase II D-LITE trial showed that there were no adverse event-related discontinuations of treatment in patients receiving a combination of peginterferon lambda-1a, ribavirin and daclatasvir. In the randomised, double-blind trial, 119 treatment-naive patients with chronic HCV genotype 1 infection received peginterferon lambda-1a combined with ribavirin and daclatasvir or asunaprevir, or peginterferon alfa-2a in combination with ribavirin, for 24 weeks. In the group receiving peginterferon lambda-1a, ribavirin and daclatasvir (n = 37), a single serious adverse event (breast cancer) was reported which was considered not to be related to the study drugs. Grade 3-4 adverse events were reported in six patients in this treatment group, with no patients experiencing alanine aminotransferase (ALT) elevations, two patients experiencing manageable aspartate aminotransferase (AST) elevations and one patient experiencing manageable elevation in total bilirubin [74] .
The most commonly reported adverse events in patients receiving peginterferon lambda-1a 180µg once weekly (n = 102) in the phase II EMERGE trial were fatigue (46%), headache (28%) and nausea (22%). Three treatment-related serious adverse events were reported in recipients of peginterferon lambda-1a 180µg (hyperbilirubinaemia [n = 1], nausea/vomiting [n = 1], and anaemia [n = 1]) and seven in recipients of peginterferon alfa-2a 180µg (sarcoidosis [n = 2], hyperbilirubinaemia [n = 1], depression/suicidal ideation [n = 1], pneumonia [n = 1], appendicitis [n = 1], and neutropenia [n = 1]). 103 patients received peginterferon alfa-2a [74] . Previously, interim results from the phase II EMERGE trial had shown that peginterferon lambda-1a (240µg), peginterferon lambda-1a (180µg) or peginterferon lambda-1a (120µg) were associated with fewer musculoskeletal adverse events than peginterferon alfa-2a (14%, 15% and 18%, respectively, vs 47% of patients) as well as fewer flu-like symptoms (10%, 10% and 13%, respectively, vs 43% of patients) in treatment-naive patients with chronic hepatitis C. Rates of serious adverse events, depression and other common adverse events were similar across arms. Aminotransferases and/or direct bilirubin elevations were most frequent on the 240 µg dose, which resolved spontaneously or following dose modifications and/or discontinuations [75] .
Interim results from phase II LIFT trial of peginterferon lambda-1-a, Lonafarnib and ritonavir for the treatment of hepatitis delta virus, showed mild to moderate side effects including GI related side effects, weight loss, anaemia and hyperbilirubinemia. Dose reduction was observed in three patients and four patients discontinued the treatment [47] [46] [45] .
Updated results of the randomized phase II LIMT HDV trial of peginterferon lambda-1a in patients (n = 33) with hepatitis D virus (HDV) infection observed mild to moderate flu-like symptoms and elevated transaminase levels as the most commonly reported adverse events, which were resolved post-treatment. Patients previously treated with peginterferon alfa noted significantly less side effects on peginterferon lambda-1a [61] . Positive end of treatment results from the randomised, open-label phase II LIMT HDV trial in patients with chronic hepatitis D virus infection demonstrated mild to moderate flu-like symptoms and elevated transaminase levels as the most common adverse events [59] . Earlier, interim results demonstrated that peginterferon lambda-1a was well tolerated, and hyperbilirubinaemia events in three patients responded to dose reduction or discontinuation. Three patients had grade 3 elevations of ALT. Three patients developed jaundice (two on 180 μg/week and one on 120 μg), two of which required permanent drug discontinuation, and one required temporary drug interruption and resumption at a reduced dose (peak direct bilirubin 86, 465 and 36 μmol/L, respectively). In all cases, jaundice was preceded by a rise in GGT. Constitutional symptoms were less frequent and milder than historical data with PEG IFN-alfa. Jaundice and bilirubin elevations were observed in the Pakistani cohort. There were no symptoms of decompensation, clinical abnormalities, ascites, worsening of synthetic function. All patients responded favourably to dose reduction or dose discontinuation [60] [57] [56] [55] .
In a phase II trial, treatment with peginterferon lambda-1a was well-tolerated in patients with COVID-2019 infections. Few adverse events were reported which included elevated transaminases which was self-resolved [31] [30] .
Phase I
final results from a phase Ib study which assessed peginterferon lambda-1a alone or in combination with ribavirin in patients with genotype 1 HCV infection with relapsed disease, and in combination with ribavirin in treatment-naive patients with genotype 1 HCV infection, showed that the most common adverse events were fatigue (29% of patients) and nausea (13%). In the single-agent arm, patients with relapsed disease (n = 24) received subcutaneous peginterferon lambda-1a 1.5 µg/kg and 3.0 µg/kg weekly for 4 weeks and 1.5 µg/kg and 3.0 µg/kg every 2 weeks. In the combination arm, patients with relapsed disease (n = 24) received subcutaneous peginterferon lambda-1a 0.5 µg/kg, 0.75 µg/kg, 1.5 µg/kg and 2.25 µg/kg weekly for 4 weeks in combination with daily oral ribavirin. Treatment-naive patients (n = 7) received subcutaneous peginterferon lambda-1a 1.5 µg/kg weekly and daily oral ribavirin. Most adverse events and laboratory changes were grade 1 or 2 in severity. Dose-limiting elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were reversible. Neutrophil counts and haematologic parameters were minimally affected [80] [81] [99] [98] [82] .
In a phase I clinical trial of healthy volunteers, peginterferon lambda-1a was well tolerated. There were no incidences of fever, significant haematologic effects or increases in IL-6 observed. The MTD was 5 µg/kg with reversible DLT, grade 3 ALT elevation, observed with two patients at a dose of 7.5 µg/kg. In addition, there was no observed myleosuppression or systemic immune activation [84] .
Preclinical
peginterferon lambda-1a did not inhibit proliferation of bone marrow cells or induce release of IL-6 by peripheral blood mononuclear cellls (PBMCs) in vitro [84] .
COVID-2019 infections:
In final results of the phase II ILIAD trial in patients with mild to moderate COVID-2019 infections, treatment of peginterferon lambda-1a was well-tolerated with few adverse events, which included minimal elevations of transaminases which self-resolved. Participants with low viral loads reported mild symptoms at baseline with symptoms improving over time in both groups [9] [28] [27] .
Phase III:
In the phase III TOGETHER trial, one COVID-19-related death observed in Lambda group and four in placebo group. Incidence of any treatment emergent adverse events were similar between subcutaneously treated peginterferon lambda 1a and placebo groups, which were primarily injection site reactions. The final data were reported from 1936 non-hospitalised adult patients with COVID-19, who are at high risk of progressing to severe illness, with 84% of patients having received at least a single dose of any COVID-19 vaccine [11] [22] [12] .
Pharmacodynamics
Summary
In a phase I clinical trial, subcutaneous administration of peginterferon lambda-1a resulted in dose dependent increases in β2-microglobulin (B2M), a biomarker for activity [84] .
Therapeutic Trials
pooled analysis:-
The pooled analysis of efficacy data from phase II LIMT-1, LOWR-3 and LIFT-1 trials showed that the combination of L-IFN plus LNF+RTV suggests a synergistic effect against HDV by 12 weeks after initiation of therapy. The coefficients of the LOWR-3 (100mg), LIMT-1, and LIFT-1 linear regressions were -0.030 (R2 = 0.045), -0.093 (R2 = 0.335), and -0.123 (R2 = 0.630), respectively. The LIFT-1 coefficient of -0.1231 is very close to the additive effect model, suggesting that the combination of L-IFN and LNF+RTV has an effect that is equal to the sum of their individual effects. In the individual patient analysis across LOWR-3 and LIFT-1 studies (n = 12), HDV RNA responses at week 12 differed by a mean of 0.97 log IU/mL (SD = 0.88). Additionally, the median HDV RNA decline from baseline after 12 weeks of therapy in LOWR-3 was 0.92 log IU/mL (p = 0.003) and LIFT-1 was 2.11 log IU/ mL (p = 0.001). The coefficients of the LOWR-3 (100mg), LIMT-1, and LIFT-1 linear regressions were -0.104 (R2 = 0.703), -0.093 (R2 = 0.335), and -0.268 (R2 = 0.737) respectively. The additive effect model of L-IFN and LNF+RTV has the coefficient -0.196, based on adding LOWR-3 and LIMT coefficients [52]
Phase II
interim results from Part A of the phase II D-LITE trial showed a sustained virologic response at 12 weeks post-treatment (SVR12) in 13 of 14 (93%) patients with hepatitis C virus (HCV) genotype 1b infection who received a combination of peginterferon lambda-1a, ribavirin and daclatasvir and achieved a protocol-defined response during treatment (HCV RNA <25 IU/mL at week 4 and HCV RNA <10 IU/mL [non-detectable] at week 12). In the randomised, double-blind trial, 119 treatment-naive patients with chronic HCV genotype 1 infection received peginterferon lambda-1a combined with ribavirin and daclatasvir or asunaprevir, or peginterferon alfa-2a in combination with ribavirin, for 24 weeks. In the group receiving peginterferon lambda-1a + ribavirin + daclatasvir (n = 41), 37 patients achieved a protocol-defined response and 28 of these (76%) achieved SVR12, with a higher response rate in patients with genotype 1b [74] .
In a phase II trial, treatment with peginterferon lambda-1a reported no difference in the duration of COVID-2019 viral shedding and time to symptom resolution when compared with placebo [31] [30] .
Results from the phase II EMERGE trial, in patients with genotype 1 or 4 chronic hepatitis C receiving ribavirin, showed that complete early virologic response (cEVR; non-detectable viral load at treatment week 4 [primary endpoint]) was reported in a significantly (p < 0.05) greater proportion of recipients of peginterferon lambda-1a 180µg once weekly than in recipients of peginterferon alfa-2a 180µg once weekly (14.7% vs 5.8%, respectively). 102 patients received peginterferon lambda-1a and 103 patients received peginterferon alfa-2a. Sustained virologic response at 24 weeks post-treatment (SVR24) rates were similar in patients receiving peginterferon lambda-1a 180µg and in those receiving peginterferon alfa-2a 180µg (37.3% vs 36.9%, respectively) [74] . Previously, interim results from the phase II EMERGE trial had shown that at 12 weeks, peginterferon lambda-1a 240µg, peginterferon lambda-1a 180µg and peginterferon lambda-1a 120µg were associated with significantly higher complete early virological response rates (co-primary endpoint) than peginterferon alfa-2a in treatment-naive patients with chronic hepatitis C (HCV) infection which was genotype 1 or 4 (56%, 56% and 55%, respectively, vs 38% of patients) but not genotype 2 or 3 (83%, 97% and 90%, respectively, vs 86% of patients) [75] . Further data from the EMERGE trial showed that patients with genotype 2 or 3 HCV infection receiving peginterferon lambda-1a had similar to peginterferon alfa-2a SVR24 rates with fewer flu-like and musculoskeletal symptoms [76] .
Updated results of the randomized phase II LIMT HDV trial in patients (n = 33) with hepatitis D virus (HDV) infection showed that peginterferon lambda-1a induced a durable virologic response (HDV RNA below limit of quantification at 24 weeks post-treatment) in 36% of patients with HDV and compensated liver disease. Liver biopsy of one patient at 18 months post-treatment, showed that HDV RNA level was undetectable at peginterferon lambda-1a end of treatment (EOT), from 3.7 log10 at baseline, with rebound to 2.6 log10 at EOT with 24 weeks of follow-up (EOFU). ALT was 169 U/L, declined to 55 U/L at EOT and remained at 54 U/L at EOFU. A reduction in liver fibrosis score from F5 (incomplete cirrhosis) to F1 (mild portal fibrosis) was observed. Liver biopsy of second patient at 18 months post-treatment, showed that HDV RNA level was undetectable at peginterferon lambda-1a EOT 4.9 log10 at baseline, with rebound to 3.6 log10 at EOFU. ALT was 159 U/L, declined to 44 U/L at EOT and peaked to 162 U/L at EOS. A reduction in liver fibrosis score from F4 (marked bridging fibrosis) to F1 (mild portal fibrosis) was observed [61] . Positive end of treatment results from the trial demonstrated better potency in HDV-infected patients, who were previously treated with alfa interferon. At week 48, patients in the 180µg and 120µg lambda treated group experienced a -2.4 log10 and -1.5 log10 mean decline in HDV-RNA, respectively. In 180 µg lambda treated group, 6 of 10 (60%) experienced 2 log10 decline and 4 of 10 (40%) patients were HDV-RNA negative at end of treatment. Additionally, in 120 µg lambda treated group, 6 of 14 (42.9%) experiencing 2 log10 decline, 2 of 14 (14.3%) patients were HDV-RNA negative at end of treatment. Earlier, interim results at 24 weeks of the randomised, open-label phase II LIMT HDV trial in patients with chronic hepatitis D virus infection demonstrated antiviral activity against hepatitis D virus infection with weekly peginterferon lambda-1a 120 μg or 180 μg SC injection, with some patients becoming PCR-negative by week 8 of therapy. The mean lab values of HDV RNA 4 .5 log10 IU/mL (SD ±1 .36); ALT 104 IU/mL (47-364 IU/mL) and bilirubin 13 μmol/L (3-20 μmol/L) at baseline. Mean Fibroscan score was 11 .8 kPA (4 .6-27 .4 kPA). Thirteen patients reached weeks 4 and 11 patients reached weeks 8 of therapy. At week 4, 23% patients (3/13) had HDV RNA < LLOQ, and one patient was PCR-negative. At week 8, 55% patients (6/11) had HDV RNA < LLOQ, out of which three were PCR-negative. HDV RNA drop from BL>2 log10 was observed in 31% patients (4/13) and 46% patients (5/11) at weeks 4 and 8, respectively. Interim results observed that by week 24, 5 out of 10 (50%) patients achieved = 2 log decline in HDV RNA and 4 of 10 (40%) patients achieved HDV PCR-negativity. During the trial, 36% durable virologic response was observed at 24 weeks post-treatment with monotherapy in patients with chronic HDV infection. At week 48, there was a mean HDV-RNA decline of 2.3 log10, with seven of 14 (50%) experiencing = 2 log10 decline and five of 14 (36%) patients achieved HDV-RNA below the limit of quantification (BLQ), compared to historical peginterferon alfa. At week 72, a durable virologic response was achieved in five of 14 (36%) patients at 24 week post treatment at 180 µg lambda, which compared favourably to historic rates for peginterferon alfa 180 µg. Increased rates of ALT normalisation were observed during post-treatment follow-up, from 14% (two of 14) at week 48 to 36% (five of 14) at week 72 [60] [101] [59] [57] [56] [55] .
Phase I
final results from a phase Ib study which assessed peginterferon lambda-1a alone or in combination with ribavirin in patients with genotype 1 HCV infection with relapsed disease, and in combination with ribavirin in treatment-naive patients with genotype 1 HCV infection, showed that maximal antiviral activity could be achieved with weekly dosing of the agent. The mean maximum decrease in HCV RNA viral load, with weekly dosing, was at least 2.0 log10 in the single agent arm and at least 3.0 log10 with combination treatment. In the single-agent arm, patients with relapsed disease (n = 24) received subcutaneous peginterferon lambda-1a 1.5 µg/kg and 3.0 µg/kg weekly for 4 weeks and 1.5 µg/kg and 3.0 µg/kg every 2 weeks. In the combination arm, patients with relapsed disease (n = 24) received subcutaneous peginterferon lambda-1a 0.5 µg/kg, 0.75 µg/kg, 1.5 µg/kg and 2.25 µg/kg weekly for 4 weeks in combination with daily oral ribavirin. Treatment-naive patients (n = 7) received subcutaneous peginterferon lambda-1a 1.5 µg/kg weekly and daily oral ribavirin [80] [82] [81] [99] [98] .
COVID-2019 infections:
Final results of phase II ILIAD trial demonstrated a single dose of lambda accelerated clearance of SARS-CoV2 in newly diagnosed, non-hospitalised patients. Among the 60 patients enrolled in the study, five required emergency room visits due to deteriorating respiratory symptoms (four in the placebo group, one in the lambda group) [9] . In the phase II ILIAD trial in patients with mild to moderate COVID-2019 infections, SARS-CoV-2 RNA viral load decline from baseline was significantly greater in the Lambda group than in the placebo group from Day 5 onwards. After controlling for baseline viral load, those treated with peginterferon lambda-1-a were 4.1-fold (95% CI 1.2-16.7, p=0.029) more likely to clear by Day 7 than those in the placebo arm. For those with baseline viral load > 6 log copies/mL, the proportion negative at Day 7 in the peginterferon lambda-1-a group was 15 of 19 (79%) compared to six of 16 (38%) in the placebo group (p=0.013). This difference translated into a median time to clearance of seven days with peginterferon lambda-1-a compared to 10 days in the placebo group (p=0.038). Consistent with recently reported studies, there was no difference in time to clearance in patients with low baseline viral loads < 6 log copies/mL: 9 of 11 (82%) in the Lambda arm and 13 of 14 (93%) in the placebo arm were negative by Day 7 (p=0.40). Across all patients, by Day 7, 24 of 30 patients (80%) in the Lambda group were negative compared to 19 of 30 (63%) in the placebo arm (p=0.15) [28] [27] .
Final results from the phase II LIFT trial of peginterferon lambda-1-a, Lonafarnib and ritonavir for the treatment of hepatitis delta virus (HDV) demonstrated that, at week 24 (end of treatment), 17 of 22 patients (77%) achieved the primary endpoint of > 2 log decline in HDV RNA, 11 of 22 patients (50%) were either HDV RNA below limit of quantitation (BLOQ) or HDV RNA undetectable, and median HDV RNA decline was 3.2 log IU/mL (CI: 2.50-3.93, p<0.0001). At Week 48 (24 weeks post-treatment), 5 of 22 patients (23%) maintained HDV RNA BLOQ or were HDV RNA undetectable, 11 of 20 patients (55%) demonstrated improvement in Histology Activity Index (HAI), and 6 of 20 patients (30%) achieved the secondary endpoint of > 2 point improvement in HAI. Updated results from phase II LIFT trial of of peginterferon lambda-1-a, Lonafarnib and ritonavir for the treatment of hepatitis delta virus (HDV) showed 25 out of 26 (96%) patients achieved >2 log decline during 24 weeks of therapy. During 12 weeks of therapy median HDV RNA decline was 3.4 log IU/ml (IQR: 2.9–3.8, p < 0.0001). Seven patients (27%) achieved undetectable HDV DNA and another six patients (23%) showed BLOQ HDV RNA. Median HDV DVA decline at the end of therapy was 3.4 log IU/mL (IQR: 2.9–4.5, p<0.0001). At the end of the therapy, 11 (42%) and three (11%) patients achieved undetectable and BLOQ HDV DNA respectively [48] [47] [100] [46] [45] .
Phase III trial:
In the phase III TOGETHER trial, single subcutaneous dose with peginterferon lambda 1a significantly reduced the risk of COVID-19-related hospitalisations or emergency room visits greater than six hours and death in non-hospitalised adult patients with COVID-19, who are at high risk of progressing to severe illness including vaccinated population. 51% reduction in COVID-19 related hospitalizations or emergency room visits greater than six hours for participants receiving peginterferon lambda vs. placebo, with 2.7% (25 of 931) of participants in the peginterferon lambda group compared with 5.6% (57 of 1018) in the placebo group. This effect was maintained in subgroup analyses including COVID-19-related hospitalization alone and COVID-19-related hospitalization or death. The effects were consistent across dominant variants and vaccination status. Among individuals with a high viral level at baseline, peginterferon lambda resulted in lower viral loads and a higher percentage of patients clearing SARS-COV-2 RNA by Day 7, compared with placebo. Peginterferon lambda was consistent in the direction of effect on all secondary outcomes. Risk of COVID-19 hospitalization or all cause death was reduced by 47% in participants receiving peginterferon lambda. In patients receiving treatment within three days of symptom onset, greater treatment effects were observed in the peginterferon lambda group, including 65% reduction of COVID-19 related hospitalization (hazard ratio 0.35, 95% Bayesian credible interval 0.15 -0.75), 81% risk reduction in all-cause death (relative risk 0.19 [0/567 vs 3/590], 95% Bayesian credible interval 0.01-1.57) and 89% risk reduction among unvaccinated patients (hazard ratio, 0.11; 95% Bayesian credible interval, 0.01 to 0.83). There was one COVID-19-related death in the peginterferon lambda group and four in the placebo group. In the trial, peginterferon lambda 1a showed highly superior effect compared with placebo on the primary endpoint with a probability of superiority of 99.91%, surpassing the prespecified superiority threshold of 97.6%. Peginterferon lambda 1a showed 50% risk reduction of COVID-19-related hospitalisations or emergency room visits compared with placebo in patients treated ≤7 days of symptom onset. In peginterferon lambda 1a group, 2.7% of patients (25/916) were hospitalised or had ER visits through Day 28, compared with 5.6% of patients (57/1020) who received placebo. There was 42% risk reduction (95% BCI: 5–66%) of COVID-19-related hospitalisations when treated with peginterferon lambda 1a for ≤7 days of symptom onset while the risk of COVID-19-related hospitalisations was reduced by 60% (95% BCI: 18–82%) when the patients were treated with peginterferon lambda 1a ≤3 days of symptom onset. Only one patient died due to COVID-19 in peginterferon lambda 1a group whereas four patients were died in placebo group. In addition, viral sequencing conducted on all patients showed that the primary endpoint was achieved across all variants tested, including omicron. The final data were reported from 1 936 patients, with 84% of patients having received at least a single dose of any COVID-19 vaccine [11] [22] [12] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Jun 2022 | Trial Update | Eiger Biopharmaceuticals plans the LIFT-2 phase II trial in Hepatitis D (Combination therapy) at National Institutes of Health in 1H 2022 (9351904) | 15 Mar 2022 |
| 31 Dec 2021 | Trial Update | Eiger BioPharmaceuticals plans a global phase III LIMT-2 trial for Hepatitis D in second half of 2021 (700307942) [10] | 08 Dec 2021 |
| 01 May 2020 | Trial Update | Eiger BioPharmaceutical in a collaboration with Massachusetts General Hospital plans a phase II trial in COVID-19 infections in USA (SC, Injection) (NCT04343976) | 01 Jul 2020 |
| 30 Apr 2020 | Trial Update | Eiger BioPharmaceuticals in collaboration with Johns Hopkins University plans a phase II trial for COVID-2019 infections (Prevention) (SC, Injection) (NCT04344600) (700320839) | 09 Jun 2020 |
| 15 Apr 2020 | Trial Update | Eiger BioPharmaceuticals plans the phase II COVID-Lambda trial for COVID-2019 infections (SC, Injection) in USA in April 2020 (NCT04331899) (320571) | 06 May 2020 |
| 31 Mar 2020 | Regulatory Status | Eiger bioPharmaceuticals plans an end-of-phase II meeting for Hepatitis D (Monotherapy) in the first quarter of 2020 [94] | 28 Apr 2020 |
| 31 Dec 2018 | Trial Update | Eiger BioPharmaceuticals plans the phase II LIFT trial (Combination therapy, in combination with ritonavir and lonafarnib) for Hepatitis D in USA in the second quarter of 2018 (700275720) [44] | 18 May 2018 |
| 31 Dec 2017 | Regulatory Status | Eiger BioPharmaceuticals plans to meet with US FDA in the fourth quarter of 2017 for discussion related to Hepatitis D treatment [95] | 28 Mar 2018 |
| 01 Jul 2017 | Regulatory Status | Eiger BioPharmaceuticals, Inc announces intention to submit IND application to US FDA for Hepatitis D [96] | 08 May 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 31 Dec 2023 | Patent Information | Eiger BioPharmaceuticals has patent protection for peginterferon lambda 1a in USA and Europe [8] Updated 11 Apr 2024 |
| 31 Dec 2023 | Patent Information | Eiger BioPharmaceuticals has patents pending for peginterferon lambda 1a in multiple countries worldwide [8] Updated 11 Apr 2024 |
| 31 Dec 2023 | Regulatory Status | Eiger Biopharmaceuticals plans to file BLA for Peginterferon lambda 1a for COVID-2019 infections and Hepatitis D [8] Updated 11 Apr 2024 |
| 10 Nov 2023 | Scientific Update | Efficacy data from a phase II LOWR-3, LIMT-1 and LIFT-1 trial in Hepatitis D presented at the 74th Annual Meeting of the American Association for the Study of Liver Diseases [52] Updated 04 Jan 2024 |
| 05 Nov 2023 | Financial Update | Credit Suisse financial data update Updated 05 Nov 2023 |
| 12 Sep 2023 | Trial Update | Eiger BioPharmaceuticals terminates the phase-III LIMT-2 trial in Hepatitis D in USA, Israel, Belgium, Bulgaria, France, Georgia, Italy, Moldova, Germany, Romania, Spain, Turkey (SC), (NCT05070364) [36] Updated 14 Sep 2023 |
| 31 Jul 2023 | Trial Update | Eiger BioPharmaceuticals completes the enrolment in the phase-III LIMT-2 trial in Hepatitis D in USA, Israel, Belgium, Bulgaria, France, Georgia, Italy, Moldova, Germany, Romania, Spain, Turkey (SC), (NCT05070364) [36] Updated 14 Sep 2023 |
| 29 Jun 2023 | Licensing Status | Peginterferon lambda 1a - Eiger BioPharmaceuticals/ZymoGenetics is available for licensing as of 29 Jun 2023. http://www.eigerbio.com Updated 16 Oct 2023 |
| 08 Feb 2023 | Scientific Update | Updated adverse events and efficacy data from the phase-III TOGETHER trial in COVID-2019 infections released by Eiger BioPharmaceuticals [11] (NCT04727424) Updated 13 Feb 2023 |
| 08 Dec 2022 | Trial Update | University Health Network completes the phase II ILIAD trial in COVID-2019 infections in Canada and Brazil (SC) (NCT04354259) Updated 25 Dec 2023 |
| 05 Oct 2022 | Regulatory Status | US FDA denies the request for a pre-EUA meeting of peginterferon lambda for the treatment of patients with COVID-19 [20] Updated 10 Oct 2022 |
| 17 Mar 2022 | Regulatory Status | Eiger BioPharmaceuticals plans to discuss the results with FDA Updated 22 Mar 2022 |
| 17 Mar 2022 | Regulatory Status | Eiger Biopharmaceuticals announces intention to submit Emergency Use Authorisation to the US FDA for COVID-2019 infections [22] Updated 21 Mar 2022 |
| 17 Mar 2022 | Scientific Update | Final efficacy and adverse events data from the phase III TOGETHER trial in COVID-2019 infections released by Eiger BioPharmaceuticals [22] Updated 21 Mar 2022 |
| 10 Mar 2022 | Trial Update | Eiger BioPharmaceuticals completes enrolment in the TOGETHER Phase-III trial in COVID-2019 infections in Brazil (SC) as of March 2022 [13] Updated 15 Mar 2022 |
| 10 Mar 2022 | Trial Update | Eiger Biopharmaceuticals plans the LIFT-2 phase II trial in Hepatitis D (Combination therapy) at National Institutes of Health in 1H 2022 [13] Updated 15 Mar 2022 |
| 23 Dec 2021 | Phase Change - III | Phase-III clinical trials in Hepatitis D in USA (SC) [37] (NCT05070364) [13] Updated 15 Mar 2022 |
| 21 Dec 2021 | Phase Change - III | Phase-III clinical trials in Hepatitis D in Israel, Belgium, Bulgaria, France, Georgia, Italy, Moldova, Germany, Romania, Spain, Turkey (SC), after December 2021 (NCT05070364) Updated 17 May 2023 |
| 11 Oct 2021 | Trial Update | Eiger BioPharmaceuticals terminates its phase II trial in COVID-19 infections in USA (SC, Injection) due to lack of funding and trial unable to meet enrolment goal (NCT04343976) Updated 18 Oct 2021 |
| 30 Sep 2021 | Trial Update | Johns Hopkins University and Eiger BioPharmaceuticals terminates the phase II PROTECT trial in COVID-2019 infections (Prevention) in USA (SC, Injection) due to low enrolment (NCT04344600) Updated 15 Oct 2021 |
| 29 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 27 Aug 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Newly diagnosed) in Canada (SC) [11] (NCT04967430) Updated 13 Feb 2023 |
| 06 May 2021 | Trial Update | Eiger BioPharmaceuticals plans a global phase III LIMT-2 trial for Hepatitis D in second half of 2021 [10] Updated 08 Dec 2021 |
| 06 May 2021 | Trial Update | Eiger BioPharmaceuticals in collaboration with the Stanford University completes a phase II trial in COVID-2019 infections in USA (SC) (NCT04331899) Updated 31 May 2021 |
| 26 Feb 2021 | Trial Update | Eiger BioPharmaceuticals and Icahn School of Medicine at Mount Sinai withdraw a phase II trial for COVID-2019 infections in USA (NCT04388709) Updated 09 Mar 2021 |
| 08 Feb 2021 | Regulatory Status | Eiger finalising regulatory guidance with the US FDA for phase II/III trial in COVID-2019 infections [9] Updated 10 Feb 2021 |
| 08 Feb 2021 | Scientific Update | Final efficacy and safety data from phase II ILIAD trial in COVID-2019 infections released by Eiger BioPharmaceuticals [9] Updated 10 Feb 2021 |
| 08 Feb 2021 | Trial Update | Eiger BioPharmaceuticals plans a registration enabling phase II/III trial in COVID-2019 infections [9] Updated 10 Feb 2021 |
| 19 Jan 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Newly diagnosed) in Brazil (SC) (NCT04727424) Updated 12 Jul 2021 |
| 17 Nov 2020 | Scientific Update | Final efficacy data from a phase II LIFT trial in Hepatitis D presented at The Liver Meeting Digital Experience™ 2020 (LMDE-2020) [48] Updated 25 Nov 2020 |
| 16 Nov 2020 | Scientific Update | Interim efficacy and adverse events data from a phase II trial in Hepatitis D released by Eiger BioPharmaceuticals [61] Updated 23 Nov 2020 |
| 09 Nov 2020 | Trial Update | National Institute of Diabetes and Digestive and Kidney Diseases and Eiger BioPharmaceuticals completes the phase II LIFT trial for Hepatitis D (Combination Therapy) in USA (SC) (NCT03600714) Updated 24 Nov 2020 |
| 09 Nov 2020 | Trial Update | Eiger BioPharmaceuticals completes enrolment in its phase II trial for Hepatitis D (Combination Therapy) in USA (NCT03600714) Updated 09 Nov 2020 |
| 15 Oct 2020 | Scientific Update | Efficacy and adverse event data from the phase II ILIAD trial in COVID-2019 infections released by Eiger BioPharmaceuticals [28] Updated 19 Oct 2020 |
| 28 Sep 2020 | Scientific Update | Safety and efficacy data from a phase II trial in COVID-2019 infections released by Eiger Biopharmaceuticals [31] Updated 30 Sep 2020 |
| 28 Sep 2020 | Trial Update | Eiger BioPharmaceuticals in collaboration with the Stanford University completes enrolment in a phase II trial in COVID-2019 infections in USA (SC) (NCT04331899) [31] Updated 30 Sep 2020 |
| 27 Aug 2020 | Scientific Update | Interim adverse events and efficacy data from a phase II LIFT trial in Hepatitis D presented at the International Liver Congress 2020 (ILC-2020) [47] Updated 15 Oct 2020 |
| 16 Aug 2020 | Trial Update | Eiger BioPharmaceuticals plans a phase III trial for Hepatitis D (SC) [32] Updated 16 Aug 2020 |
| 06 Aug 2020 | Regulatory Status | Eiger BioPharmaceuticals completes single, phase III study design agreement with FDA and EMA for Hepatitis D [32] Updated 12 Aug 2020 |
| 22 Jun 2020 | Trial Update | Eiger BioPharmaceutical in a collaboration with Massachusetts General Hospital initiates a phase II trial in COVID-19 infections in USA (SC, Injection) (NCT04343976) Updated 01 Jul 2020 |
| 29 May 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in USA (SC) (NCT04344600) Updated 09 Jun 2020 |
| 18 May 2020 | Trial Update | Eiger BioPharmaceuticals and Icahn School of Medicine at Mount Sinai plans a phase II trial for COVID-2019 infections in USA (NCT04388709) Updated 20 May 2020 |
| 13 May 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in Canada and Brazil (SC) (NCT04354259) Updated 22 May 2020 |
| 24 Apr 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in USA (SC) [29] (NCT04331899) Updated 06 May 2020 |
| 16 Apr 2020 | Trial Update | Eiger BioPharmaceuticals in collaboration with Johns Hopkins University plans a phase II trial for COVID-2019 infections (Prevention) (SC, Injection) (NCT04344600) Updated 09 Jun 2020 |
| 14 Apr 2020 | Trial Update | Eiger BioPharmaceutical in a collaboration with Massachusetts General Hospital plans a phase II trial in COVID-19 infections in USA (SC, Injection) (NCT04343976) Updated 01 Jul 2020 |
| 02 Apr 2020 | Trial Update | Eiger BioPharmaceuticals plans the phase II COVID-Lambda trial for COVID-2019 infections (SC, Injection) in USA in April 2020 (NCT04331899) Updated 06 May 2020 |
| 01 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (SC) prior to April 2020 [33] Updated 07 Apr 2020 |
| 01 Apr 2020 | Trial Update | Eiger BioPharmaceuticals plans a multiple investigator-sponsored trial for COVID-2019 infections in USA [33] Updated 07 Apr 2020 |
| 13 Mar 2020 | Regulatory Status | Eiger BioPharmaceuticals plans to finalise scientific advice from European medical agency (EMA) Updated 30 Mar 2020 |
| 31 Dec 2019 | Regulatory Status | Eiger bioPharmaceuticals completes an end-of-phase II meeting with the US FDA [40] Updated 28 Apr 2020 |
| 07 Nov 2019 | Regulatory Status | Eiger bioPharmaceuticals plans an end-of-phase II meeting for Hepatitis D (Monotherapy) in the first quarter of 2020 [94] Updated 28 Apr 2020 |
| 22 Oct 2019 | Scientific Update | Interim efficacy and safety data from a phase II LIFT trial in Hepatitis D released by Eiger BioPharmaceuticals [46] Updated 30 Oct 2019 |
| 20 Aug 2019 | Regulatory Status | Peginterferon lambda-1a - Eiger BioPharmaceuticals receives Breakthrough Therapy status for Hepatitis D in USA [34] Updated 21 Aug 2019 |
| 20 Aug 2019 | Regulatory Status | Peginterferon lambda-1a - Eiger BioPharmaceuticals receives Orphan Drug status for Hepatitis D in European Union before August 2019 [34] Updated 21 Aug 2019 |
| 10 Jun 2019 | Regulatory Status | Eiger BioPharmaceuticals plans to conduct an end of phase II meeting for discussions regarding development in Hepatitis D [41] Updated 14 Jun 2019 |
| 17 May 2019 | Trial Update | Eiger BioPharmaceuticals plans a phase III trial in Hepatitis D [38] [32] Updated 20 May 2019 |
| 30 Apr 2019 | Regulatory Status | Eiger BioPharmaceuticals plans for the approval of peginterferon alpha for Hepatitis D Updated 03 May 2019 |
| 11 Apr 2019 | Scientific Update | Efficacy and adverse events data from the phase II LIMT HDV trial in Hepatitis D released by Eiger BioPharmaceuticals [60] Updated 18 Apr 2019 |
| 12 Dec 2018 | Trial Update | Eiger BioPharmaceuticals completes a phase II trial for Hepatitis D in Israel, New Zealand and Pakistan (SC) (NCT02765802) Updated 25 Feb 2019 |
| 17 Oct 2018 | Scientific Update | Positive efficacy and adverse events data from a phase II LIMT HDV trial in Hepatitis D released by Eiger BioPharmaceuticals [59] Updated 25 Oct 2018 |
| 11 May 2018 | Phase Change - II | Phase-II clinical trials in Hepatitis D (Combination therapy) in USA (SC) Updated 18 May 2018 |
| 21 Mar 2018 | Trial Update | Eiger BioPharmaceuticals plans the phase II LIFT trial (Combination therapy, in combination with ritonavir and lonafarnib) for Hepatitis D in USA in the second quarter of 2018 [44] Updated 18 May 2018 |
| 23 Oct 2017 | Scientific Update | Interim efficacy and safety data from the phase II LIMT HDV trial in Hepatitis D released by Eiger BioPharmaceuticals [56] Updated 26 Oct 2017 |
| 20 Oct 2017 | Scientific Update | Interim efficacy and adverse events data from a phase II LIMT HDV trial in Hepatitis D presented at the The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2017) [57] Updated 15 Nov 2017 |
| 05 Sep 2017 | Regulatory Status | Peginterferon lambda-1a receives Orphan Drug status for Hepatitis D in USA [35] Updated 07 Sep 2017 |
| 14 Aug 2017 | Regulatory Status | Eiger BioPharmaceuticals plans to meet with US FDA in the fourth quarter of 2017 for discussion related to Hepatitis D treatment [95] Updated 28 Mar 2018 |
| 27 Jul 2017 | Phase Change - Preclinical | Preclinical trials in Hepatitis D in USA (SC) Updated 17 Nov 2017 |
| 27 Jul 2017 | Regulatory Status | Peginterferon lambda-1a receives Fast Track designation for Hepatitis D [SC,Injection] in USA [49] Updated 17 Nov 2017 |
| 27 Jul 2017 | Regulatory Status | Peginterferon lambda-1a receives Fast track status from the US FDA for Hepatitis D [49] Updated 28 Jul 2017 |
| 24 Jul 2017 | Trial Update | Eiger BioPharmaceuticals completes enrolment in its phase II LIMT HDV trial for Hepatitis D in New Zealand, Israel and Pakistan (SC) [53] Updated 27 Jul 2017 |
| 12 May 2017 | Regulatory Status | The US FDA approves IND application for Hepatitis D [50] Updated 29 May 2017 |
| 03 May 2017 | Phase Change - II | Phase-II clinical trials in Hepatitis D in Israel, Pakistan (SC) prior to May 2017 [51] Updated 08 May 2017 |
| 03 May 2017 | Regulatory Status | Eiger BioPharmaceuticals files an IND application with the US FDA for Hepatitis D [51] Updated 08 May 2017 |
| 23 Mar 2017 | Patent Information | Eiger BioPharmaceuticals has patent protection for peginterferon lambda in US [93] Updated 12 May 2017 |
| 23 Mar 2017 | Regulatory Status | Eiger BioPharmaceuticals, Inc announces intention to submit IND application to US FDA for Hepatitis D [96] Updated 08 May 2017 |
| 17 Feb 2017 | Patent Information | Eiger BioPharmaceuticals files for patent protection for peginterferon lambda 1a worldwide [8] [92] Updated 11 Apr 2024 |
| 01 Aug 2016 | Phase Change - II | Phase-II clinical trials in Hepatitis D in New Zealand (SC) (NCT02765802) Updated 16 Aug 2016 |
| 06 May 2016 | Trial Update | Eiger BioPharmaceuticals plans a phase II trial for Hepatitis D in New Zealand (SC) (NCT02765802) Updated 11 May 2016 |
| 20 Apr 2016 | Licensing Status | Peginterferon lambda 1a licensed to Eiger BioPharmaceuticals worldwide [2] Updated 22 Apr 2016 |
| 27 Aug 2015 | Trial Update | Bristol-Myers Squibb terminates phase-III DIMENSION trial in Hepatitis C (combination therapy, treatment-naive) in Argentina, Belgium, Canada, United Kingdom, France, Germany, Italy, Mexico, Poland, Russia, Spain, and USA (SC, injection) due to sponsor decision not based on any new unexpected safety findings or efficacy observations (NCT01866930) Updated 22 Jun 2023 |
| 01 May 2015 | Trial Update | Bristol-Myers Squibb completes a phase III trial in Hepatitis C (Combination therapy) in USA, United Kingdom, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, the Netherlands, Poland, Russia, Spain, and Switzerland (NCT01598090) Updated 04 Apr 2016 |
| 25 Apr 2015 | Trial Update | Bristol-Myers Squibb completes the phase III MAGNITUDE trial in Hepatitis C in USA, Australia, France, Italy, Netherlands, Romania, Russia and Spain (NCT01741545) Updated 25 Apr 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C (Combination therapy) in Israel, Switzerland, Brazil, Austria (SC) Updated 05 Apr 2016 |
| 31 Dec 2014 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Hepatitis B (Treatment-naive) in USA, Australia, Canada, France, Netherlands, Germany, Taiwan, Singapore, Hong Kong (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Hepatitis C (Combination therapy, Treatment-naive) in Germany, Puerto Rico (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(II/III) | Discontinued - Phase-II/III for Hepatitis C (Combination therapy, Treatment-naive) in New Zealand (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C (Combination therapy) in Germany (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C (Combination therapy) in Israel (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C (Combination therapy, Treatment-naive) in Canada, USA, Chile, Greece, Hong Kong, Russia, Belgium, Netherlands, France, United Kingdom, Italy, Australia, Finland, Argentina, Taiwan, Singapore, Mexico, Czech Republic, South Korea, Poland, Japan (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C (Combination therapy, Treatment-naive, Treatment-experienced) in USA, Australia, France, Italy, Netherlands, Romania, Russia, Spain (SC) Updated 07 May 2015 |
| 31 Dec 2014 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Hepatitis C in Argentina, Belgium, Finland, Greece, Mexico, Netherlands, South Korea (SC) Updated 07 May 2015 |
| 01 Nov 2014 | Trial Update | Bristol-Myers Squibb completes a phase III trial in Hepatitis C in USA, Canada, Argentina, Australia, European Union, Mexico, South Korea and Puerto Rico (NCT01525810) Updated 29 Apr 2015 |
| 01 Nov 2014 | Trial Update | Bristol-Myers Squibb completes the phase III BASIS trial in Hepatitis C in Czech Republic, Mexico, Poland and South Korea (NCT01754974) Updated 11 Dec 2014 |
| 01 Oct 2014 | Trial Update | Bristol-Myers Squibb completed the phase III STRUCTURE trial in Hepatitis C (Combination treatment) in USA, Argentina, France, Germany, Israel, Italy, Japan, South Korea, Poland, Russia, Spain, Taiwan and United Kingdom (NCT01718158) Updated 01 Dec 2014 |
| 24 Sep 2014 | Trial Update | Bristol-Myers Squibb completes the phase III PRINCIPAL trial in Hepatitis C (Combination therapy, Treatment-naive) in USA, Argentina, Australia, Belgium, Chile, Finland, France, Greece, Hong Kong Italy, Japan, South Korea, Mexico, Netherlands, New Zealand, Russia, Singapore, Taiwan and United Kingdom (NCT01616524) Updated 24 Nov 2014 |
| 01 Sep 2014 | Trial Update | Bristol-Myers Squibb completes the phase II D-LITE trial in Hepatitis C (Combination therapy, Treatment-naive) in USA and European Union (NCT01795911) Updated 13 Feb 2015 |
| 01 Sep 2014 | Trial Update | Bristol-Myers Squibb completes the phase II D-LITE trial (Part A and B) in Hepatitis C (Combination therapy, Treatment-naive) in USA, Australia, France, Germany, Italy, Japan, New Zealand, Puerto Rico and Spain (NCT01309932) Updated 07 Oct 2014 |
| 19 Aug 2014 | Trial Update | Bristol-Myers Squibb completes enrolment in the phase II D-LITE trial for Hepatitis C (Combination therapy, Treatment-naive) in USA and European Union (NCT01795911) Updated 29 Aug 2014 |
| 18 Jul 2014 | Trial Update | Bristol-Myers Squibb suspends the phase III BASIS trial in Hepatitis C in Czech Republic, Mexico, Poland and South Korea (NCT01754974) Updated 18 Jul 2014 |
| 01 Dec 2013 | Trial Update | Bristol-Myers Squibb completes a phase II trial in Hepatitis B (treatment-naive) in USA, Canada, Australia, the EU, Hong Kong, South Korea, Singapore and Taiwan (NCT01204762) Updated 14 Jul 2014 |
| 13 Aug 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (co-infection with HIV, combination therapy, treatment-naive) in Canada (SC) Updated 22 Aug 2013 |
| 13 Aug 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (co-infection with HIV, combination therapy, treatment-naive) in USA (SC) Updated 22 Aug 2013 |
| 11 Jul 2013 | Trial Update | Bristol-Myers Squibb initiates phase-III DIMENSION trial in Hepatitis C (combination therapy, treatment-naïve ) in Argentina, Belgium, Canada, United Kingdom, France, Germany, Italy, Mexico, Poland, Russia, Spain, and USA (SC, injection) (NCT01866930) Updated 22 Jun 2023 |
| 05 Jun 2013 | Trial Update | Bristol-Myers Squibb plans a phase III trial in Hepatitis C (combination therapy, treatment-naive patients) in Latin America, Europe, and North America (NCT01866930) Updated 26 Jun 2013 |
| 31 Mar 2013 | Trial Update | Bristol-Myers Squibb initiates enrolment in D-LITE (part C) phase II trial for Hepatitis C (treatment-naive, combination therapy) in the USA (NCT01795911) Updated 22 Jul 2013 |
| 01 Mar 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy, Treatment-naive, Treatment-experienced) in Australia, France, Italy, the Netherlands, Romania, Russsia and Spain (SC) Updated 24 Apr 2015 |
| 01 Mar 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive patients) in Czech Republic (SC) after March 2013 Updated 14 Jul 2014 |
| 01 Mar 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive patients) in Poland (SC) after March 2013 Updated 14 Jul 2014 |
| 01 Mar 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive patients) in South Korea (SC) after March 2013 Updated 14 Jul 2014 |
| 01 Mar 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive patients) in Mexico (SC) Updated 15 Jul 2013 |
| 01 Mar 2013 | Trial Update | Bristol-Myers Squibb completes its phase I trial in subjects with normal renal function or renal dysfunction in USA (NCT01708889) Updated 25 Jun 2013 |
| 15 Feb 2013 | Trial Update | Bristol-Myer Squibb plans a phase III trial for genotype 1 Hepatitis C (treatment-naive patients) (NCT01754974) Updated 15 Feb 2013 |
| 01 Feb 2013 | Trial Update | Bristol-Myers Squibb completes enrolment in its phase I trial in subjects with normal renal function or renal dysfunction in USA (NCT01708889) Updated 13 Mar 2013 |
| 18 Jan 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy) in Germany (SC) Updated 22 Feb 2013 |
| 01 Jan 2013 | Trial Update | Bristol-Myers Squibb initiates enrolment in a phase III trial for Hepatitis C (Combination therapy) in Spain (NCT01718158) Updated 24 Apr 2015 |
| 01 Jan 2013 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy) in Israel after January 2013 (SC) (NCT01718158) Updated 01 Dec 2014 |
| 14 Dec 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive) in Argentina (SC) Updated 25 Jan 2013 |
| 14 Dec 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive) in Australia (SC) Updated 25 Jan 2013 |
| 14 Dec 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive) in Finland (SC) Updated 25 Jan 2013 |
| 14 Dec 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy, Treatment-naive) in Belgium (SC) Updated 13 Aug 2012 |
| 14 Dec 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy, Treatment-naive) in Netherlands (SC) Updated 13 Aug 2012 |
| 13 Nov 2012 | Scientific Update | Interim efficacy and adverse events data from a Phase-IIb trial in Hepatitis C genotype 1 (combination therapy, treatment-naive patients) presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2012) [74] Updated 30 Nov 2012 |
| 13 Nov 2012 | Scientific Update | Interim efficacy and adverse events data from a Phase-IIb trial in Hepatitis C genotypes 1 and 4 (combination therapy, treatment-naive patients) presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2012) [74] Updated 30 Nov 2012 |
| 02 Nov 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive) in France (SC) Updated 25 Jan 2013 |
| 02 Nov 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (combination therapy, treatment-naive) in Italy (SC) Updated 25 Jan 2013 |
| 30 Jul 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C in USA (SC) Updated 13 Aug 2012 |
| 01 Jul 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy, Treatment-naive) in Japan, New Zealand, Chile, Greece, Hong Kong, Russia, Singapore, Taiwan and United Kingdom after July 2012 (SC) (NCT01616524) Updated 24 Nov 2014 |
| 07 Jun 2012 | Trial Update | Bristol-Myers Squibb plans a phase III trial for Hepatitis C in USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, Finland, France, Greece, Hong Kong, India, Italy, Japan, Mexico, Netherlands, New Zealand, Russia, Singapore, South Korea, Taiwan and United Kingdom (NCT01616524) Updated 21 Jun 2012 |
| 01 Jun 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C (Combination therapy) in Switzerland, Israel, Brazil, Austria (SC) (NCT01598090) after June 2012 Updated 05 Apr 2016 |
| 21 May 2012 | Trial Update | Bristol-Myers Squibb plans a Phase-III trial for Hepatitis-C (combination therapy) in multiple countries (NCT01598090) Updated 14 Jun 2012 |
| 20 Apr 2012 | Scientific Update | Efficacy data from the phase IIb EMERGE trial presented at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL-2012) [76] Updated 30 Apr 2012 |
| 14 Mar 2012 | Trial Update | Bristol-Myers Squibb initiates worldwide enrolment in a three-year follow-up for Hepatitis C (NCT01525810) Updated 10 Apr 2012 |
| 01 Mar 2012 | Phase Change - III | Phase-III clinical trials in Hepatitis C in Argentina, Belgium, Finland, Greece, Mexico, Netherlands, South Korea (SC) (NCT01525810) Updated 29 Apr 2015 |
| 01 Jan 2012 | Phase Change - II | Phase-II clinical trials in Hepatitis C (combination therapy, treatment-naive) in Poland (SC) Updated 25 Jan 2013 |
| 02 Dec 2011 | Trial Update | ZymoGenetics completes enrolment in a phase II trial (EMERGE) in chronic Hepatitis C in USA, Canada, Puerto Rico, the EU and Australia (NCT01001754) Updated 16 Jan 2012 |
| 30 Aug 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B (Treatment-naive) in Netherlands (SC) Updated 25 Jan 2013 |
| 06 Jul 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment-naive patients, combination therapy) in Spain (SC) Updated 12 Oct 2011 |
| 01 Jun 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment-naive patients, combination therapy) in New Zealand (SC) Updated 12 Oct 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment-naive patients, combination therapy) in Germany (SC) Updated 12 Oct 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment-naive patients, combination therapy) in Japan (SC) Updated 12 Oct 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment-naive patients, combination therapy) in Italy (SC) Updated 12 Oct 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Hong Kong (SC) Updated 05 May 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Singapore (SC) Updated 05 May 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B in South Korea (SC) Updated 05 May 2011 |
| 28 Apr 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Taiwan (SC) Updated 05 May 2011 |
| 03 Apr 2011 | Scientific Update | Interim efficacy and adverse events data from the phase II EMERGE trial in Hepatitis C presented at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL-2011) [75] Updated 04 Apr 2011 |
| 31 Mar 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (combination therapy) in France (SC) Updated 27 Apr 2011 |
| 31 Mar 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis C (combination therapy) in USA (SC) Updated 27 Apr 2011 |
| 10 Feb 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B (Treatment-naive) in Germany (SC) Updated 25 Jan 2013 |
| 10 Jan 2011 | Phase Change - II | Phase-II clinical trials in Hepatitis B (Treatment-naive) in France (SC) Updated 25 Jan 2013 |
| 31 Dec 2010 | Phase Change - No development reported(Preclinical) | No development reported - Preclinical for Multiple sclerosis in USA (Parenteral) Updated 11 Mar 2011 |
| 13 Oct 2010 | Company Involvement | ZymoGenetics has been acquired by Bristol-Myers Squibb Updated 11 Oct 2010 |
| 08 Sep 2010 | Company Involvement | Bristol-Myers Squibb agrees to acquire ZymoGenetics , Updated 08 Sep 2010 |
| 01 Sep 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis C (combination therapy, treatment-naive) in Romania (SC) Updated 25 Jan 2013 |
| 26 Aug 2010 | Trial Update | ZymoGenetics completes enrolment in its phase IIb (part 2) EMERGE trial for treatment-naive Hepatitis C in USA and Puerto Rico Updated 26 Aug 2010 |
| 02 Jun 2010 | Trial Update | ZymoGenetics initiates phase IIb (part 2) of the EMERGE trial for treatment-naive Hepatitis C in USA and Puerto Rico Updated 03 Jun 2010 |
| 31 May 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis C in Australia (SC) Updated 05 May 2011 |
| 31 May 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis C in Canada (SC) Updated 05 May 2011 |
| 18 Apr 2010 | Scientific Update | Pharmacokinetics data from a phase Ib trial in Hepatitis C presented at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL-2010) [97] Updated 22 Apr 2010 |
| 06 Jan 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Australia (SC) Updated 17 Jan 2011 |
| 06 Jan 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Canada (SC) Updated 17 Jan 2011 |
| 06 Jan 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis B in France (SC) Updated 17 Jan 2011 |
| 06 Jan 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis B in Italy (SC) Updated 17 Jan 2011 |
| 06 Jan 2010 | Phase Change - II | Phase-II clinical trials in Hepatitis B in USA (SC) Updated 17 Jan 2011 |
| 01 Nov 2009 | Scientific Update | Final efficacy and adverse events data from a Phase-II trial in Hepatitis C presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2009) [80] Updated 05 Nov 2009 |
| 27 Oct 2009 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment naive patients) in USA (SC) Updated 03 Jun 2010 |
| 27 Oct 2009 | Phase Change - II | Phase-II clinical trials in Hepatitis C (treatment naive patients) in Puerto Rico (SC) Updated 30 Oct 2009 |
| 24 Apr 2009 | Scientific Update | Interim efficacy and adverse events data from a phase Ib trial in Hepatitis C presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL-2009) [81] , [82] Updated 30 Apr 2009 |
| 04 Mar 2009 | Licensing Status | The collaboration between ZymoGenetics and Bristol-Myers Squibb for PEG-interleukin-29 is cleared under provisions of the the Hart-Scott-Rodino Antitrust Improvements Act [6] Updated 04 Mar 2009 |
| 13 Jan 2009 | Licensing Status | PEG-interleukin-29 licensed to Bristol-Myers Squibb worldwide [5] Updated 15 Jan 2009 |
| 31 Dec 2008 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Cancer in USA (Parenteral) Updated 30 Oct 2009 |
| 04 Nov 2008 | Scientific Update | Interim adverse events and efficacy data from a phase Ib trial in Hepatitis C presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2008) [98] Updated 17 Nov 2008 |
| 27 Apr 2008 | Scientific Update | Adverse events, pharmacokinetics and pharmacodynamics data from a phase I trial in healthy volunteers and preclinical studies presented at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL-2008) [84] Updated 02 May 2008 |
| 31 Dec 2007 | Trial Update | ZymoGenetics initiates enrolment in a Phase Ib trial for Hepatitis C in USA Updated 02 May 2008 |
| 12 Jun 2007 | Phase Change - Preclinical | Preclinical trials in Cancer in USA (Parenteral) Updated 12 Jun 2007 |
| 12 Jun 2007 | Phase Change - Preclinical | Preclinical trials in Multiple sclerosis in USA (Parenteral) Updated 12 Jun 2007 |
| 30 Jan 2007 | Phase Change - I | Phase-I clinical trials in Hepatitis C in USA (unspecified route) Updated 05 Feb 2007 |
| 30 Nov 2006 | Regulatory Status | ZymoGenetics files an IND with the FDA in the US for PEG-interleukin-29 Updated 28 Feb 2007 |
| 28 Jul 2005 | Phase Change - Preclinical | Preclinical trials in Hepatitis C in USA (unspecified route) Updated 05 Feb 2007 |
| 06 Jul 2004 | Phase Change - Preclinical | Preclinical trials in Viral infections in USA (unspecified route) Updated 05 Feb 2007 |
References
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Eiger BioPharmaceuticals to Focus on Metabolic Diseases with Avexitide; David Apelian Takes Helm as CEO.
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Bristol-Myers Squibb Completes Acquisition of ZymoGenetics, Inc.
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Bristol-Myers Squibb and ZymoGenetics Enter Global Collaboration on Novel Hepatitis C Compound.
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ZymoGenetics Collaboration with Bristol-Myers Squibb Clears Review Under Hart-Scott-Rodino Antitrust Improvements Act.
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ZymoGenetics Licenses Ex-North American Rights to Three Proteins with Antiviral and Anti-Inflammatory Disease Therapeutic Potential to Novo Nordisk.
Media Release -
Eiger BioPharmaceuticals_10-K_SEC-filing_Dec-2023. Internet-Doc 2024;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1305253/000162828024015297/eigr-20231231.htm -
Eiger Announces ILIAD Study Results of Peginterferon Lambda in COVID-19 Published in Lancet Respiratory Medicine 2021.
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Eiger BioPharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update.
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New England Journal of Medicine Publishes Positive Phase 3 TOGETHER Results with Peginterferon Lambda in COVID-19.
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A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Interferon Lambda 1A, Fluvoxamina + Budesonida, Fluoxetina + Budesonida in Mild COVID-19 and High Risk of Complications
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Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update.
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Eiger BioPharmaceuticals Announces Outlook and Planned 2022 Catalysts and Milestones.
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Eiger BioPharmaceuticals Announces Peginterferon Lambda to be Added to Multi-Center Phase 3 TOGETHER COVID-19 Study in Brazil.
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Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients.
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Eiger BioPharmaceuticals Announces Interim Analysis and Continuation of Dosing of Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients.
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Eiger BioPharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update.
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Eiger BioPharmaceuticals Announces Second Positive Interim Analysis and Continuation of Dosing of Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Patients.
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Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback.
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Eiger BioPharmaceuticals Provides Update on Status of Planned Peginterferon Lambda COVID-19 Emergency Use Authorization Application.
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Eiger BioPharmaceuticals to Host Conference Call to Discuss Phase 3 TOGETHER Study Results of Peginterferon Lambda for COVID-19 on Thursday, March 17, 2022.
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A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
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A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
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Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
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Eiger BioPharmaceuticals: SEC filing, Form 10-K, March 2022. Internet-Doc 2022;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1305253/000156459022009697/eigr-10k_20211231.htm -
Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
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Eiger BioPharmaceuticals Announces Positive Results of Investigator Sponsored Randomized Controlled Trial at University of Toronto with Peginterferon Lambda in Outpatients with Mild to Moderate COVID-19.
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Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda.
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A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19
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Eiger Announces Results of Investigator Sponsored Study in Outpatients with Mild and Uncomplicated COVID-19.
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Eiger BioPharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update.
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Eiger BioPharmaceuticals Provides Update on Clinical Development Activities and Business Operations During COVID-19 Pandemic.
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Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection.
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Eiger Announces FDA Orphan Drug Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.
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Eiger to Discontinue Phase 3 LIMT-2 Trial of Peginterferon Lambda in Patients with Chronic Hepatitis Delta.
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Eiger BioPharmaceuticals Announces First Patient Enrolled in LIMT-2: A Phase 3 Study of Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection.
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Eiger BioPharmaceuticals Announces Transition of Chief Operating Officer and Executive Medical Officer.
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Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)
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FORM-10K. Internet-Doc 2020;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1305253/000156459020010645/eigr-10k_20191231.htm -
Eiger Appoints Industry Veteran and Regulatory Affairs Expert Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs.
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Eiger BioPharmaceuticals Reports on 2018 R&D Day.
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Eiger BioPharmaceuticals Announces First Patient Enrolled in Phase 2 LIFT Study of Pegylated Interferon Lambda in Combination with Ritonavir-Boosted Lonafarnib at National Institutes of Health.
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Eiger BioPharmaceuticals Announces Positive Guidance Following FDA Meeting on Hepatitis Delta Virus Registration Program.
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Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
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Eiger Announces Peginterferon Lambda Combination Therapy for Treatment of Chronic Hepatitis Delta Virus (HDV) Infection to be Featured in a Late-Breaking Oral Presentation at AASLD 2019.
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Koh C, Hercun J, Rahman F, Huang A, Da B, Surana P, et al. A Phase 2 Study of Peginterferon Lambda, Lonafarnib and Ritonavir for 24 Weeks: End-of-Treatment Results from the LIFT HDV Study. ILC-2020 2020; abstr. LBP13.
Available from: URL: http://ilc-congress.eu/ -
Eiger Announces Positive Peginterferon Lambda - Lonafarnib Combination End of Study Results from Phase 2 LIFT HDV Study in Late-Breaker Session at The Liver Meeting Digital Experience(TM) 2020.
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Eiger Announces FDA Fast Track Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.
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Eiger BioPharmaceuticals Reports First Quarter 2017 Financial Results.
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Eiger Announces U.S. IND Filing of Pegylated Interferon Lambda for Hepatitis Delta Virus Infection.
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Park C, Hercun J, Dahari H, Etzion O, Hamid SS, Gane EJ, et al. Understanding the Antiviral Effects of Peginterferon Lambda with and Without Ritonavir Boosted Lonafarnib in Chronic Hepatitis D Infection. AASLD-2023 2023; abstr. 1252-C.
Available from: URL: https://www.aasld.org/the-liver-meeting -
Eiger Completes Enrollment in Phase 2 LIMT HDV Study of Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.
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Eiger Announces First Patient Dosed in Phase 2 Study of Pegylated Interferon Lambda in Hepatitis D Virus (HDV) Infection.
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A Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT)
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Eiger Announces Positive Phase 2 Interim 24-Week Data with Pegylated Interferon Lambda in Hepatitis Delta Virus (HDV) Infection at the American Association for the Study of Liver Diseases (AASLD) Meeting.
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Hamid SS, Etzion O, Lurie Y, Bader N, Yardeni D, Channa SM, et al. A Phase 2 Randomized Clinical Trial to Eval-uate the Safety and Efficacy of Pegylated Inter-feron Lambda Monotherapy in Patients with Chronic Hepatitis Delta Virus Infection. Interim Results From the LIMT HDV Study. AASLD-2017 2017; abstr. 927.
Available from: URL: http://onlinelibrary.wiley.com/doi/10.1002/hep.29501/epdf -
Eiger BioPharmaceuticals Reports Second Quarter 2018 Financial Results.
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Eiger BioPharmaceuticals Announces Positive Phase 2 LIMT Study End of Treatment Data with Pegylated Interferon Lambda Monotherapy in Hepatitis Delta Virus (HDV) Infection.
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Eiger Announces 36% Durable Virologic Response at 24 Weeks Post-Treatment with Peginterferon Lambda in Phase 2 LIMT HDV Study at The International Liver Congress(TM) 2019.
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Eiger Announces Case Studies Demonstrating Regression of Liver Fibrosis Following 48 Weeks of Therapy with Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection Presented at The Liver Meeting Digital Experience(Tm) 2020.
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A Phase 3 Evaluation of Daclatasvir in Combination with Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination with Peginterferon Alfa-2a and RBV in Patients with Chronic Hepatitis C Genotype 1b who are Treatment Naïve or Prior Relapsers to Alfa/RBV Therapy (The STRUCTURE Study)
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A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin
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A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin
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A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C
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A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 2 and 3 Chronic Hepatitis C Subjects
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A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects
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Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naive Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV
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A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects.
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Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG interleukin-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
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ZymoGenetics Initiates Phase 2 Clinical Trial of PEG-Interferon lambda in Hepatitis C with Bristol-Myers Squibb.
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ZymoGenetics Initiates PEG-Interferon lambda Phase 2b Clinical Trial in Hepatitis C in Collaboration with Bristol-Myers Squibb.
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ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with PEG-Interferon lambda in Hepatitis C.
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Bristol-Myers Squibbs Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of Genotype 1b Treatment-Naive Patients In Phase IIb Study.
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Zeuzem S, Arora S, Bacon B, Box T, Charlton M, Diago M, et al. PEGYLATED INTERFERON-LAMBDA (PEGIFN-LAMBDA) SHOWS SUPERIOR VIRAL RESPONSE WITH IMPROVED SAFETY AND TOLERABILITY VERSUS PEGIFN ALPHA-2A IN HCV PATIENTS (G1/2/3/4): EMERGE PHASE IIB THROUGH WEEK 12. 46th-EASL-2011 2011; abstr. N/A.
Available from: URL: http://www.easl.eu -
Bristol-Myers Squibb Delivers a Solid First Quarter with Strong Operating Results and Key R&D Milestones.
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A Phase 2B, randomized study to evaluate the safety and efficacy of Pegylated Interferon Lambda (BMS-914143) administered with Ribavirin plus a single direct antiviral agent (BMS-790052 or BMS-650032) versus Pegasys administered with Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) administered with or without Ribavirin plus 2 direct antiviral agents (BMS 790052 and BMS-650032) (Part B) in chronic hepatitis C genotype-1 treatment naive subjects
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A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naive Subjects
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A Phase 1 Study to Assess the Safety and Antiviral Activity of PEG-rIL-29 Administered as a Single Agent and in Combination With Ribavirin in Treatment-Relapsed and Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
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Bristol-Myers Squibb and ZymoGenetics Present Final Phase 1b Results for PEG-Interferon Lambda in Hepatitis C.
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Shiffman M, Lawitz E, Zaman A, Vierling J, Yoffe B, FREEMAN J, et al. PEG-IFN-lambda: antiviral activity and safety profile in a 4-week phase 1B study in relapsed genotype 1 hepatitis c infection. 44th-EASL-2009 2009; abstr. 520.
Available from: URL: http://www2.kenes.com -
Bristol-Myers Squibb and ZymoGenetics Present Positive 4-week Results of PEG-Interferon lambda with Ribavirin in Hepatitis C.
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ZymoGenetics Reports Second Quarter 2008 Financial Results.
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Freeman JA, Zhang T, Holdren MS, Hausman DF. PEG-interferon lambda (PEG-IL-29): translation of in vitro preclinical data to clinical results. 43rd-Ann-Meet-Eur-Assoc-Study-Liver 2008; (plus poster).
Available from: URL: http://www.easl.ch/liver-meeting -
ZymoGenetics Reports Second Quarter 2007 Financial Results.
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ZymoGenetics Begins Clinical Trial for PEG-Interferon lambda as Potential Treatment for Viral Infection.
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Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive Revised Protocol 04, incorporating Protocol Amendments 02, 03, 04 and 05
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An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
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Eiger Completes $25 Million Debt Financing with Oxford Finance.
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Eiger BioPharmaceuticals Announces Pricing of Public Offering of Common Stock.
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Eiger BioPharmaceuticals Announces Proposed Public Offering of Common Stock.
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Patent. Internet-Doc 2024;.
Available from: URL: https://patents.google.com/patent/US10953072B2/en?q=(10%2c953%2c072) -
Eiger BioPharmaceuticals Form 10-K, March 2017. Internet-Doc 2017;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1305253/000156459017005079/eigr-10k_20161231.htm -
Eiger BioPharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update.
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Eiger BioPharmaceuticals Reports Second Quarter 2017 Financial Results.
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Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results.
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Byrnes-Blake KA, Freeman JA, Dodds MG, Rapalus L, Pederson S, Hunder N, et al. Pharmacokinetics of peg-interferon lambda (PEG-INF-lamda) in a dose-ranging phase 1B study in hepatitis C patients. 45th-EASL-2010 2010;.
Available from: URL: http://www.easl.ch/easl2010 -
Lawitz EJ, Zaman A, Muir AJ, Shiffman ML, Yoffe B, Zhang T, et al. Interim results from a phase 1b dose-escalation study of 4 weeks of peg-interferon lambda treatment in subjects with hepatitis C virus genotype 1 with prior virologic response and relapse to peginterferon alfa and ribavirin. 59th-AASLD-2008 2008;385 abstr. 170.
Available from: URL: http://www.aasld.org -
ZymoGenetics Presents Positive Interim Phase 1b Results in Hepatitis C.
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Eiger Updates on 2019 Progress and 2020 Milestones Expected.
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Eiger Late-Breaker Oral Presentation of Peginterferon Lambda Phase 2 LIMT Study at The International Liver Congress(Tm) 2019.
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