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Peginterferon lambda-1a - Eiger BioPharmaceuticals

Drug Profile

Peginterferon lambda-1a - Eiger BioPharmaceuticals

Alternative Names: BMS-914143; Lambda - Eiger BioPharmaceuticals; PEG-IL-29 - ZymoGenetics; PEG-interferon lambda; PEG-interleukin-29 - ZymoGenetics; PEG-rIL-29 - ZymoGenetics; Pegylated interferon lambda - Eiger BioPharmaceuticals

Latest Information Update: 22 May 2020

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

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hepatitis D
  • New Molecular Entity No

Highest Development Phases

  • Phase II COVID 2019 infections; Hepatitis D
  • No development reported Multiple sclerosis
  • Discontinued Cancer; Hepatitis B; Hepatitis C

Most Recent Events

  • 18 May 2020 Eiger BioPharmaceuticals and Icahn School of Medicine at Mount Sinai plans a phase II trial for COVID-2019 infections in USA (NCT04388709)
  • 13 May 2020 Phase-II clinical trials in COVID-2019 infections in Canada (SC) (NCT04354259)
  • 24 Apr 2020 Phase-II clinical trials in COVID-2019 infections in USA (SC) (NCT04331899)

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. 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 New Zealand, Israel and Pakistan and in the US. Clinical development for COVID-2019 infections is underway in the US 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.

Company Agreements

In April 2016, Eiger Biopharmaceuticals obtained exclusive worldwide license from Bristol Mayers Squibb, 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. [1]

In October 2010, ZymoGenetics was acquired by Bristol-Myers Squibb [2] . Prior to the acquisition, Bristol-Myers Squibb and ZymoGenetics were involved in a global collaboration for peginterferon λ-1a [3] [4] .

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 [5] . However, this agreement is no longer active.

Key Development Milestones

COVID-2019 infections

In May 2020, University Health Network initiated the phase II ILIAD trial to evaluate effect of subcutaneous peginterferon lambda-1a for the Treatment of COVID-2019 infections (NCT04354259; JF-4-2020). The randomised, quadruple blind trial intends to enrol approximately 140 patients in Canada [6] .

In April 2020, Eiger BioPharmaceuticals in collaboration with the Stanford University initiated and dosed the first patient in a phase II study to evaluate 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 trial will also evaluate the efficacy of the drug in reducing duration of symptoms and hospitalization in patients with mild COVID-2019 infections. The randomised, single-blind, open-label trial intends to enrol approximately 120 patients in the US [7] [8] .

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 [9] .

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 [10] . In September 2017, the US FDA granted orphan drug status to peginterferon lambda-1a for the treatment of chronic hepatitis delta virus (HDV) infections [11] .

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 [12] . In June 2019, Eiger BioPharmaceuticals reported of its intention to conduct an end of phase II meeting, for discussions regarding development in Hepatitis D [13] .

Eiger BioPharmaceuticals is planning a phase III study of peginterferon lambda-1a for the treatment of hepatitis delta virus infections [14] .

In March 2018, Eiger BioPharmaceuticals reported that the company had a face-to-face interaction with the US FDA, in February 2018, regarding hepatitis D programme. Based on the discussions with the FDA, the company initiated the phase II LIFT (Lambda InterFeron combo-Therapy) trial in May 2018, in approximately 26 HDV-infected patients. The open-label trial enrolled its first patient in August 2018 and is designed to evaluate the combination of lambda-1a, lonafarnib [see AdisInsight drug profile 800009901] and ritonavir [see AdisInsight drug profile 800004117] in the US. As of December 2018, 24 of 26 patents were enrolled in the trial [15] [16] [17] [18] . In October 2019, Eiger BioPharmaceuticals released 24 week interim safety and efficacy results from the trial [19] .

In July 2017, the US FDA granted fast track designation to peginterferon λ-1a for the treatment of hepatitis D virus infections [20] . 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 [21] . The company intends to expand the ongoing LIMT HDV study [see below] to sites in the US [22] .

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 (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 [23] [22] [24] [25] . Interim results of the trial were released by the company [26] . 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) [27] . Eiger announced the completion of doing in August 2018 [28] . Positive week 48 results from the trial were released by Eiger BioPharmaceuticals in October 2018 [29] . In April 2019, Eiger BioPharmaceuticals released 48 and 72 week safety and efficacy results from the trial [30] .

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

A phase III STRUCTURE trial that was completed by Bristol-Myers Squibb (BMS) in October 2014, 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 (NCT01718158; EudraCT2011-005409-65). The trial enrolled is 444 patients who were treatment naive or previous relapsers to therapy with peginterferon-α-2a and ribavirin. Patients were enrolled in the US, Argentina, France, Germany, Israel, Italy, Japan, South Korea, Poland, Russia, Spain, Taiwan and the UK [31] .

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 [32] .

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 [33] .

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 [34] .

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 [35] .

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 [36] .

A similar phase III trial, initiated in August 2013, aims 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 (NCT01866930; EudraCT2012-003280-22). Approximately 300 patients are expected to be enrolled in Argentina, Belgium, Canada, the UK, France, Germany, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, and the US. As of August 2013, recruitment had begun in Canada and the US [37] .

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 [38] .

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 [39] . Dosing of the first patient triggered a milestone payment of $US70 million to ZymoGenetics from Bristol-Myers Squibb [40] . The second (phase IIb) part of the EMERGE trial was initiated in June 2010 [41] [42] . Results were reported in April 2011, April 2012 and December 2012 [43] [44] [45] .

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 [46] . Positive interim results were reported at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2012) [43] . 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 [47] .

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) [48] . Final results were reported at the annual meeting of the American Association for the Study of Liver Diseases (AASLD-2009) [49] [50] [51] [52] .

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 [53] [54] .

In vitro

antiviral activity against several viruses, including HCV, has been demonstrated with peginterferon λ-1a [55] . 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 [56] .

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 [57] .

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 [58] .

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] [59] [60] .

Patent Information

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 [61] .

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

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Phase II USA SC / Injection Eiger BioPharmaceuticals, Inc. 24 Apr 2020
COVID 2019 infections - - Phase II Canada SC / Injection University Health Network 13 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 - Combination therapy Phase II USA (fast track) SC / Injection Eiger BioPharmaceuticals, Inc. 11 May 2018
Hepatitis D - - Phase II Israel, 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 US Hepatitis D

Orphan Status

Indication Patient Segment Country Organisation Event Date
Hepatitis D - USA Eiger BioPharmaceuticals, Inc. 05 Sep 2017
Hepatitis D - European Union Eiger BioPharmaceuticals, Inc. 20 Aug 2019

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

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 - - - - 02 Apr 2020
Hepatitis C Wrld (50% US) - Development Stopped - - - - 02 Apr 2020

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 [65] .

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 [53] .

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 [43] .

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 [43] . 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 [44] .

Interim results from phase II LIFT trial for the treatment of hepatitis delta virus, showed mild to moderate side effects including GI related side effects, weight loss, anaemia and hyperbilirubinemia [19] [18] .

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 [29] . 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 [30] [27] [26] [25] .

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 [49] [50] [67] [66] [51] .

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 [53] .

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 [53] .

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 [53] .

Therapeutic Trials

Interim results from phase II LIFT trial for the treatment of hepatitis delta virus (HDV), showed that 53% of patients with HDV RNA and lower limit of quantification (BLOQ) RNA were detectable at week 24. Also, 36% of patients with HDV RNA were undetectable at week 24. Around 95% of patients achieved the primary endpoint of greater than 2 log decline in HDV RNA at week 24. At week 12, the median HDV RNA showed decline from baseline of 3.6 log IU/mL, five patients showed undetectable HDV RNA and another five patients showed BLOQ HDV RNA. Median baseline evaluations included: ALT (64 IU/mL), AST (47 IU/mL), Ishak Fibrosis (3), modified HAI inflammation (9), HBV DNA (< 21 IU/mL) and log HDV RNA (4.74 IU/mL). In 19 out of 26 patients the median HDV RNA decline was 3.4 IU/mL, whereas seven patients achieved undetectable HDV RNA and three patients with BLOQ HDV RNA [68] [19] [18] .

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 [43] .

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) [43] . 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) [44] . 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 [45] .

Positive end of treatment results from the randomised, open-label phase II LIMT HDV trial in patients with chronic hepatitis D virus infection 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 [30] [69] [29] [27] [26] [25] .

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 [49] [51] [50] [67] [66] .

Future Events

Expected Date Event Type Description Updated
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) 23 Apr 2020
30 Apr 2020 Trial Update Eiger BioPharmaceuticals in collaboration with Johns Hopkins University plans a phase II trial for COVID-2019 infections (In adults, In elderly) (NCT04344600) (700320839) 16 Apr 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 [62] 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) [17] 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 [63] 28 Mar 2018
01 Jul 2017 Regulatory Status Eiger BioPharmaceuticals, Inc announces intention to submit IND application to US FDA for Hepatitis D [64] 08 May 2017

Development History

Event Date Update Type Comment
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 (SC) (NCT04354259) Updated 22 May 2020
24 Apr 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections in USA (SC) [7] (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 (In adults, In elderly) (NCT04344600) Updated 16 Apr 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 23 Apr 2020
08 Apr 2020 Regulatory Status NCT04331899: FET added for p-II trial, CTP added and assumed trial location USA Updated 08 Apr 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
02 Apr 2020 Financial Update Credit Suisse financial data update Updated 11 Apr 2020
01 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (SC) prior to April 2020 [9] Updated 07 Apr 2020
01 Apr 2020 Trial Update Eiger BioPharmaceuticals plans a multiple investigator-sponsored trial for COVID-2019 infections in USA [9] 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 [12] 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 [62] 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 [19] Updated 30 Oct 2019
20 Aug 2019 Regulatory Status Peginterferon lambda-1a - Eiger BioPharmaceuticals receives Breakthrough Therapy status for Hepatitis D in USA [10] 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 [10] 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 [13] Updated 14 Jun 2019
17 May 2019 Trial Update Eiger BioPharmaceuticals plans a phase III trial in Hepatitis D [14] 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 [30] 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 [29] 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 [17] 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 [26] 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) [27] Updated 15 Nov 2017
05 Sep 2017 Regulatory Status Peginterferon lambda-1a receives Orphan Drug status for Hepatitis D in USA [11] 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 [63] 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 [20] Updated 17 Nov 2017
27 Jul 2017 Regulatory Status Peginterferon lambda-1a receives Fast track status from the US FDA for Hepatitis D [20] 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) [23] Updated 27 Jul 2017
12 May 2017 Regulatory Status The US FDA approves IND application for Hepatitis D [21] 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 [22] Updated 08 May 2017
03 May 2017 Regulatory Status Eiger BioPharmaceuticals files an IND application with the US FDA for Hepatitis D [22] Updated 08 May 2017
23 Mar 2017 Patent Information Eiger BioPharmaceuticals has patent protection for peginterferon lambda in US [61] Updated 12 May 2017
23 Mar 2017 Regulatory Status Eiger BioPharmaceuticals, Inc announces intention to submit IND application to US FDA for Hepatitis D [64] Updated 08 May 2017
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 [1] Updated 22 Apr 2016
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
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) [43] 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) [43] 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) [45] 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) [44] 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) [65] 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) [49] 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) [50] , [51] 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 [4] Updated 04 Mar 2009
13 Jan 2009 Licensing Status PEG-interleukin-29 licensed to Bristol-Myers Squibb worldwide [3] 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) [66] 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) [53] 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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    Media Release
  2. Bristol-Myers Squibb Completes Acquisition of ZymoGenetics, Inc.

    Media Release
  3. Bristol-Myers Squibb and ZymoGenetics Enter Global Collaboration on Novel Hepatitis C Compound.

    Media Release
  4. ZymoGenetics Collaboration with Bristol-Myers Squibb Clears Review Under Hart-Scott-Rodino Antitrust Improvements Act.

    Media Release
  5. ZymoGenetics Licenses Ex-North American Rights to Three Proteins with Antiviral and Anti-Inflammatory Disease Therapeutic Potential to Novo Nordisk.

    Media Release
  6. 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

    ctiprofile
  7. Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda.

    Media Release
  8. A Phase 2 Randomized, Single Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

    ctiprofile
  9. Eiger BioPharmaceuticals Provides Update on Clinical Development Activities and Business Operations During COVID-19 Pandemic.

    Media Release
  10. Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection.

    Media Release
  11. Eiger Announces FDA Orphan Drug Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.

    Media Release
  12. Eiger Appoints Industry Veteran and Regulatory Affairs Expert Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs.

    Media Release
  13. Eiger BioPharmaceuticals Announces Transition of Chief Operating Officer and Executive Medical Officer.

    Media Release
  14. Eiger BioPharmaceuticals Reports on 2018 R&D Day.

    Media Release
  15. 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.

    Media Release
  16. Eiger BioPharmaceuticals Announces Positive Guidance Following FDA Meeting on Hepatitis Delta Virus Registration Program.

    Media Release
  17. Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon

    ctiprofile
  18. 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.

    Media Release
  19. Eiger Announces FDA Fast Track Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.

    Media Release
  20. Eiger BioPharmaceuticals Reports First Quarter 2017 Financial Results.

    Media Release
  21. Eiger Announces U.S. IND Filing of Pegylated Interferon Lambda for Hepatitis Delta Virus Infection.

    Media Release
  22. Eiger Completes Enrollment in Phase 2 LIMT HDV Study of Pegylated Interferon Lambda in Hepatitis Delta Virus Infection.

    Media Release
  23. Eiger Announces First Patient Dosed in Phase 2 Study of Pegylated Interferon Lambda in Hepatitis D Virus (HDV) Infection.

    Media Release
  24. 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)

    ctiprofile
  25. 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.

    Media Release
  26. 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
  27. Eiger BioPharmaceuticals Reports Second Quarter 2018 Financial Results.

    Media Release
  28. Eiger BioPharmaceuticals Announces Positive Phase 2 LIMT Study End of Treatment Data with Pegylated Interferon Lambda Monotherapy in Hepatitis Delta Virus (HDV) Infection.

    Media Release
  29. 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.

    Media Release
  30. 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)

    ctiprofile
  31. 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

    ctiprofile
  32. 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

    ctiprofile
  33. 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

    ctiprofile
  34. 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

    ctiprofile
  35. 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

    ctiprofile
  36. 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

    ctiprofile
  37. 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.

    ctiprofile
  38. 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 [Estudio de fase 2a/b, aleatorizado y controlado, de la eficacia y la seguridad de PEG-rIL-29 administrado en combinacion con ribavirina a sujetos con infeccion cronica por el virus de la hepatitis C no tratada previamente].

    ctiprofile
  39. ZymoGenetics Initiates Phase 2 Clinical Trial of PEG-Interferon lambda in Hepatitis C with Bristol-Myers Squibb.

    Media Release
  40. ZymoGenetics Initiates PEG-Interferon lambda Phase 2b Clinical Trial in Hepatitis C in Collaboration with Bristol-Myers Squibb.

    Media Release
  41. ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with PEG-Interferon lambda in Hepatitis C.

    Media Release
  42. 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.

    Media Release
  43. 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
  44. Bristol-Myers Squibb Delivers a Solid First Quarter with Strong Operating Results and Key R&D Milestones.

    Media Release
  45. 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

    ctiprofile
  46. 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

    ctiprofile
  47. 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

    ctiprofile
  48. Bristol-Myers Squibb and ZymoGenetics Present Final Phase 1b Results for PEG-Interferon Lambda in Hepatitis C.

    Media Release
  49. 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
  50. Bristol-Myers Squibb and ZymoGenetics Present Positive 4-week Results of PEG-Interferon lambda with Ribavirin in Hepatitis C.

    Media Release
  51. ZymoGenetics Reports Second Quarter 2008 Financial Results.

    Media Release
  52. 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
  53. ZymoGenetics Reports Second Quarter 2007 Financial Results.

    Media Release
  54. ZymoGenetics Begins Clinical Trial for PEG-Interferon lambda as Potential Treatment for Viral Infection.

    Media Release
  55. 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

    ctiprofile
  56. 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

    ctiprofile
  57. Eiger Completes $25 Million Debt Financing with Oxford Finance.

    Media Release
  58. Eiger BioPharmaceuticals Announces Pricing of Public Offering of Common Stock.

    Media Release
  59. Eiger BioPharmaceuticals Announces Proposed Public Offering of Common Stock.

    Media Release
  60. 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
  61. Eiger BioPharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update.

    Media Release
  62. Eiger BioPharmaceuticals Reports Second Quarter 2017 Financial Results.

    Media Release
  63. Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results.

    Media Release
  64. 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
  65. 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
  66. ZymoGenetics Presents Positive Interim Phase 1b Results in Hepatitis C.

    Media Release
  67. Eiger Updates on 2019 Progress and 2020 Milestones Expected.

    Media Release
  68. Eiger Late-Breaker Oral Presentation of Peginterferon Lambda Phase 2 LIMT Study at The International Liver Congress(Tm) 2019.

    Media Release
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