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Bamlanivimab - Abcellera/Eli Lilly and Company

Drug Profile

Bamlanivimab - Abcellera/Eli Lilly and Company

Alternative Names: LY 3819253; LY CoV 555

Latest Information Update: 21 Sep 2021

At a glance

  • Originator Abcellera; Eli Lilly and Company
  • Developer Abcellera; Eli Lilly and Company; National Institute of Allergy and Infectious Diseases
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action Virus internalisation inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered COVID 2019 infections

Most Recent Events

  • 16 Sep 2021 Registered for COVID-2019 infections (Combination therapy, In the elderly, Prevention, In adults) in USA (IV)
  • 05 Sep 2021 Eli Lilly completes enrolment in the phase II BLAZE-4 trial for COVID-2019 infections (In adults, Combination therapy) in Argentina, Puerto Rico and USA (IV, infusion) (NCT04634409)
  • 05 Sep 2021 Eli Lilly completes enrolment in the phase II BLAZE-4 trial for COVID-2019 infections (In adults, Monotherapy) in Argentina, Puerto Rico and USA (IV, infusion) (NCT04634409)

Development Overview

Introduction

Bamlanivimab (formerly known as LY CoV 555, LY 3819253) is a recombinant, neutralising human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2, being developed by Eli Lilly and AbCellera, in collaboration with National Institute of Allergy and Infectious Disease, for the treatment and prevention of COVID-2019 infections. Bamlanivimab has been developed using AbCellera's pandemic response platform, which is a microfluidic platform that uses miniaturised assays to screen antibodies from individual B cells from any species, including directly from human patients. Bamlanivimab neutralises the virus and potentially prevents and treats COVID-2019 by blocking the viral attachment and entry into human cells. It is also capable of neutralising the N439K variant. Bamlanivimab is awaiting approval as monotherapy and is approved as a combination therapy in the US, under emergency use authorisation for COVID-2019 infections. Bamlanivimab is approved both as monotherapy and combination therapy in Italy under emergency use authorisation for COVID-2019 infections. Candidate is also approved under emergency pathway as a monotherapy in Czech Republic, Canada, Germany, Israel, Sweden, Panama, Kuwait and UAE and also authorised for emergency use in Rwanda and Morocco in collaboration with Bill & Melinda Gates Foundation. Bamlanivimab alone and in combination with etesevimab is authorised for emergency use in the US for the prevention of COVID-2019 infections and is under regulatory review in the EU for the treatment of COVID-2019 infections. Late stage clinical development is underway in multiple countries.

Bamlanivimab has advanced from a research programme for coronavirus neutralising antibodies by Eli Lilly and AbCellera [See Adis Insight drug profile 800057369].

Company Agreements

In September 2021, Eli Lilly and Company entered into a Joint Procurement Agreement with European Commission to supply up to 220,000 doses of bamlanivimab along with etesevimab to treat confirmed COVID-2019 infections in patients of age 12 years and above not requiring supplemental oxygen for COVID-2019 and who are at increased risk of progressing to severe infection. The agreement will help to provide access to treatments by enabling participating countries in the European Union (EU) and the European Economic Area (EEA) to purchase the drugs directly from Eli Lilly following national approval for emergency use or marketing authorization at the EU level. [1]

In September 2021, Eli Lilly announced an additional purchase by the US government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the US government, with approximately 200,000 doses expected to ship in Q3 2021 and the remaining to be shipped in Q4. This transaction is expected to generate approximately $US330 million in revenue in the second half of 2021. Earlier, in April 2021, Eli Lilly and the US government have agreed to modify the purchase agreement of bamlanivimab alone and focus on supply of bamlanivimab and etesevimab together. Additionally, the bamlanivimab and etesevimab agreement has been modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased, some of which have already been delivered to sites of care. This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. Lilly's bamlanivimab received emergency use authorisation from the US FDA. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone. Earlier, as of December 2020, Eli Lilly and Company has entered to a supply agreement with the US government, to supply multiple doses of Eli Lilly's bamlanivimab 700 mg for the treatment of COVID-2019 infections. The agreement is for $US812.5 million and the doses will be delivered through January 2021. In December 2020, The U.S. government has purchased 650 000 additional drug doses, the totaling to 950 000 doses of bamlanivimab. Additional 350 000 doses will delivered later in the same month. [2] [3] [4]

In April 2021, Eli Lilly and Company reported that the purchase agreement with the U.S. government for bamlanivimab alone was terminated, and orders were cancelled for the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. In February 2021, Junshi Biosciences and Eli Lilly and Company announced that the US Government agreed to purchase a minimum of 100,000 doses of etesevimab (JS016 or LY-CoV016) 1400 mg [see Adis Insight Drug profile800058525] and bamlanivimab (LY-CoV555) 700 mg [see Adis Insight Drug profile800058899] together. Additionally, the National Institutes of Health (NIH) recently updated the COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression. The agreement is for $210 million and 450,000 doses will be delivered through March 31, 2021. The U.S. government will have the option to purchase up to an additional 1,100,000 doses through November 25, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability and the medical need in the US. The federal government directs the distribution of etesevimab and bamlanivimab together. Other details of the agreement have not been disclosed. [5] [6] [7]

In January 2021, Eli Lilly, Vir Biotechnology and GlaxoSmithKline entered an agreement to evaluate bamlanivimab in combination with VIR 7831 for mild to moderate COVID-2019 infections. Eli Lilly will expand its ongoing BLAZE-4 trial to evaluate the efficacy of combined therapy. [8]

In December 2020, Eli Lilly and Company entered into partnership with UnitedHealth Group (UnitedHealthcare Services) to conduct a pragmatic study of bamlanivimab in high-risk, COVID-2019 infected patients that meet Emergency Use Authorization (EUA) criteria as per the US FDA. Under the study design, UnitedHealth Group with its Optum health services will conduct a study in real world settings, which will detect high-risk symptomatic patients with COVID-2019 infections, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home treatment with bamlanivimab infusion. The aim of the collaborative endeavour is to reduce the severity of illness and hospitalisations. The study will enroll up to 500 000 patients, with at least 5 000 people expected to receive bamlanivimab therapy. [9]

In November 2020, Samsung Biologics and Eli Lilly and Company entered into a long-term manufacturing agreement to accelerate global supply of COVID-19 antibody treatments. This agreement with Samsung supplements Lilly's own internal manufacturing capacity. Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May 2020 to address the demand for COVID-19 treatments worldwide. Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) meeting Good Manufacturing Practices (GMP) and regulatory expectations within 5 months of contract signing. The timeline for tech transfer was less than 3 months [10]

In September 2020, Eli Lilly and Company and Amgen entered a global antibody manufacturing collaboration to increase the supply capacity available for Lilly's potential COVID-19 therapies, including LY-CoV-555. Amgen will leverage its technical expertise in antibody development and its capabilities in the scale up and manufacturing of complex biologics. Further details of the agreement were not disclosed. [11]

In July 2020, Sanford Burnham Prebys Medical Discovery Institute entered into an research agreement with Eli Lilly and Company to characterize Lilly’s next-generation anti-SARS-CoV-2 antibodies. The research team will evaluate antibody candidates, delivered from Lilly through their partnership with AbCellera, using the live virus in the Institute’s Biosafety Level 3 (BSL-3) laboratory. [12]

In March 2020, Abcellera and Eli Lilly entered into a research and development agreement to develop antibodies for up to nine Eli Lilly-selected therapeutic targets. One of therapeutic targets is for treatment and prevention of COVID-19 infections, caused by SARS-CoV-2 coronavirus. Eli Lilly will select up to eight additional targets during the multi-year agreement. Abcellera's rapid pandemic response platform developed under the DARPA Pandemic Prevention Platform (P3) programme will be used in this collaboration along with Eli lilly's rapid development, manufacturing and distribution of therapeutic antibodies. Under the terms of agreement Abcellera and Eli lilly will together fund the initial development cost of the product, after which Eli lilly will be responsible for all further development, manufacturing and distribution. Eli lilly has paid AbCellera an up-front payment and will pay preclinical, clinical, and commercial milestones and tiered royalties on future sales. [13] [14]

Key Development Milestones

In March 2021, CHMP started a ‘rolling review’ of data on the antibodies bamlanivimab and etesevimab to be used in combination for the treatment of COVID-19 infections. The review will also look at bamlanivimab used alone [15] . Earlier, in March 2021, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab [see Adis Insight Drug profile 800058525]. The opinion recommended administration of bamlanivimab alone and combination of bamlanivimab with etesevimab will be used for the treatment of confirmed COVID-2019 infection in patients, aged 12 years and older that do not require supplemental oxygen for COVID-2019 and who are at high risk of progressing to severe COVID-2019 infections. The CHMP opinion was based from the phase II and phase III BLAZE-1 trials [see below] [16] . Earlier, in February 2021, the bamlanivimab plus etesevimab [see Adis Insight Drug profile 800058525] regimen was authorized for use in Italy, for the treatment of mild to moderate COVID-2019 infections [17] . In the same month, the European Medical Agency's (EMA) human medicines committee (CHMP) initiated a rolling review of data on the use of bamlanivimab alone and in combination with etesevimab for the treatment of COVID-2019 infection in patients who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-2019. The CHMP decision to start rolling review based on preliminary results from a study indicates that reduced the viral load in the back of the nose and throat of non hospitalized patients with COVID-19 who do not need supplementation oxygen [18] .

In April 2021, the US FDA revoked the emergency use authorisation (EUA) of bamlanivimab 700 mg alone, for the treatment of mild-to-moderate COVID-2019 infection in adults and certain paediatric patients, as the criteria for issuance of an authorisation were not met. The decision was made based on the scientific data, which included sustained increase of SARS-CoV-2 viral variants that were resistant to bamlanivimab alone which resulted in the increased risk for treatment failure [19] . In the same month, Eli Lilly and Company had requested the US FDA to revoke the Emergency Use Authorization (EUA). The request was made due to the evolving variant landscape in the US and the full availability of bamlanivimab and etesevimab [see Adis Insight Drug profile 800058525] together. This request was not due to any new safety concern. This was taken as a final step in Lilly's transition to only supply bamlanivimab and etesevimab together for administration in the US for the treatment of COVID-2019 infection– as planned with the US FDA – following the modification of contracts with the US government to ensure adequate supply of etesevimab to be used together with bamlanivimab [20] . Previously in November 2020, AbCellera had announced that bamlanivimab 700 mg received an emergency use authorization (EUA) from the US FDA. Bamlanivimab is authorised for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older with positive results of direct SARS-CoV-2 viral testing, who weigh at least 40 kg and are at high risk for progressing to severe COVID-19 and/or hospitalisation. The EUA is based on data from the two randomised trials namely; BLAZE-1 and BLAZE-2 [see below]. In February 2021, the infusion time was authorized at 16 minutes, significantly reduced from the previously approved time of 60 minutes. As of October 2020, Eli Lilly and Company submitted an initial request for emergency use authorization (EUA) to US FDA for bamlanivimab (LY CoV555) monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 infection, based on the combination therapy data [17] [21] .

In September 2021, AbCellera announced that, the US FDA has expanded the Emergency Use Authorization (EUA) for bamlanivimab administered with etesevimab [see Adis Insight Drug profile800058525] to include post-exposure prophylaxis (PEP) to prevent COVID-2019 infection. The expanded EUA is based on data from the phase 3 BLAZE-2 trial [See below] [22] [23] .

In February 2021, the US FDA granted Emergency Use Authorization (EUA) for etesevimab [see Adis Insight Drug profile 800058525] and bamlanivimab combination therapy, for the treatment of mild to moderate COVID-2019 infection in high-risk patients aged 12 years and older who are high risk for progressing to severe COVID-2019 and/or hospitalization. The therapies are indicated to be infused together in a single IV infusion, as soon as possible after a positive test and within 10 days of symptom onset. The infusion time has been authorized at 21 minutes. The EUA request was submitted by Eli Lilly, in November 2020, based on the phase II/III BLAZE-1 trial data [see below] [17] [24] [25] .

In November 2020, Health Canada granted authorisation to bamlanivimab under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19, as a treatment for adults and paediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalisation. This authorisation was based on data from BLAZE-1 trial [see below] [26] .

As of March 2021, Bamlanivimab alone is authorisd under special/emergency pathways in Czech Republic, Germany, Israel, Italy, Hungary, Sweden, Panama, Kuwait and UAE. In addition, bamlanivimab alone has been authorised for emergency use in Rwanda and Morocco, and through Lilly's work with the Bill & Melinda Gates Foundation, as company is providing doses of the medicine free of charge in these countries [27] [28] .

As of November 2020, Eli Lilly was in discussions with global regulators including from India, Brazil, Russia and Europe for pursuing authorisation of bamlanivimab for COVID-2019 infections [26] .

In August 2020, National Institute of Allergy and Infectious Diseases initiated a phase III TICO (ACTIV-3) trial to evaluate the safety and efficacy of multiple investigational agents (either LY 3819253, remdesivir, VIR 7831, BRII 196/BRII 198, AZD 7442 and ensovibep) plus standard of care for the treatment of COVID-19 positive adults in the hospitalised setting (014 / ACTIV-3; NCT04501978; EudraCT2020-003278-37). The trial is designed as part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. The randomised trial intends to enrol 10000 patients in Hungary, Netherlands, Denmark, Greece, Poland, Singapore, Spain, Switzerland, Sweden, Uganda, United Kingdom and the US and may expand to India [29] .

In December 2020, Eli Lilly and company in collaboration with UnitedHealth Group, initiated the pragmatic UNITED trial to assess the efficacy and safety of bamlanivimab versus a propensity matched cohort for the treatment of symptomatic, high-risk COVID-2019 patients in the outpatient setting (2020-0081; NCT04639479). Trial participants will track for symptom development and in-home SARS-CoV-2 testing. If positive, the patients will receive a one-time at-home infusion of bamlanivimab, 700mg. The primary objective is to determine the incidence of COVID-2019 related hospitalisation at day 28 among bamlanivimab-treated participants relative to external, propensity-matched controls. The trial will also evaluate the incidence of COVID-related mortality at day 28, as well as safety of bamlanivimab. The trial is intended to enroll up to 500 000 patients, with at least 5 000 expected to receive bamlanivimab therapy [9] [30] .

In November 2020, Eli Lilly and company completed an expanded access programme for COVID-2019 infections in the US. In October 2020, Eli Lilly Company initiated an expanded access programme for COVID-2019 infections in the US (18165; J2X-MC-Y001; NCT04603651) [31] .

In August 2020, National Institute of Allergy and Infectious Diseases and Eli Lilly initiated the phase II/III Adapt Out COVID trial to evaluate the safety and efficacy of bamlanivimab (LY CoV 555, LY 3819253), as compared with a placebo constituted of a 0.9% sodium chloride solution, for the treatment of COVID-19 infections (NCT04518410; ACTIV-2; ACTIV2; A5401; 38742; DAIDS-ES). The randomised trial intends to enrol 2 000 patients in the US and Puerto Rico [32] .

In August 2020, National Institute of Allergy and Infectious Diseases initiated phase III TICO trial to evaluate the safety and efficacy of bamlanivimab and standard of care drug remdesivir [see Adis Insight Drug profile800043325] for the treatment of COVID-19 infections (NCT04501978; ACTIV-3; 014; 014ACTIV3). The primary endpoint of the trial is sustained recovery of the participants for 14 days, following release from the hospital. The randomised, blinded, controlled, multicentre trial intends to enrol 10 000 patients in USA [29] . In October 2020, Independent data safety monitoring board (DSMB) recommended to pause enrolment in its ongoing phase III trial [33] .

In May 2021, Eli Lilly, in collaboration with AbCellera Biologics and National Institute of Allergy and Infectious Diseases, completed a phase III BLAZE-2 trial that evaluated bamlanivimab alone and in combination with etesevimab (LY 3832479/LY CoV016) [see Adis Insight Drug profile800058525] to prevent COVID-2019 infections (NCT04497987; 18063; J2X-MC-PYAD; CoVPN #3501). The randomised study was initiated in August 2020 and enrolled 1374 participants in the US. The study was run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). In August 2020, National Institute of Allergy and Infectious Diseases reported that enrollment of healthy adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection in the trial has been initiated in the US [34] [35] [36] . In January 2021, results from the trial were released by the company [37] [38] . In January 2021, efficacy data from a trial in COVID-2019 infections was released by Eli Lilly and Company. In March 2021, Eli Lilly and Company presented safety and efficacy data from a phase III trial at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [39] [40] .

In June 2021, Eli Lilly and Company in collaboration with AbCellera Biologics completed the phase II BLAZE-5 trial which evaluated the real-world effectiveness of bamlanivimab in patients with mild-to-moderate COVID-2019 infections (NCT04701658; J2X-MC-PYAJ; 18216). The open-label, prospective cohort trial was initiated in February 2021 and enrolled 3000 patients in the US [41] .

In October 2020, Eli Lilly and Company initiated a phase II BLAZE-4 trial to evaluate the efficacy and safety of etesevimab (LY 3832479/LY CoV016) [see Adis Insight Drug profile800058525] and bamlanivimab (LY 3819253/LY CoV555) as monotherapy and combination therapy in patients with mild to moderate COVID-2019 infections (NCT04634409; J2X-MC-PYAH). The randomised, placebo-controlled trial is designed to enrol approximately 1782 patients in the US, Argentina and Puerto Rico [42] [43] . In January 2021, Eli Lilly expanded the trial to evaluate bamlanivimab in combination with sotrovimab [see Adis Insight Drug profile800058114] in patients with mild to moderate COVID-2019 infections. Subsequently, first patient was dosed in the trial [8] . In March 2021, Eli lilly and company reported that the BLAZE-4 trial met primary end point in which combination of bamlanivimab, 700mg with sotrovimab, 500mg showed significant reduction in high viral load by 70% (> 5.27; cycle threshold value < 27.5) at day 7 compared with placebo [44] [17] . In September 2021, Eli Lilly reported that the trial has completed patient enrollment [1] .

In January 2021, the phase II/III BLAZE-1 trial met the primary and secondary endpoints of the study by significantly reducing viral load and accelerated symptom resolution with the combination therapy of bamlanivimab and etesevimab, in patients with COVID-2019 infections (17947; J2W-MC-PYAB; NCT04427501). In June 2020, Eli Lilly, in collaboration with AbCellera Biologics, initiated the trial to evaluate safety and efficacy of bamlanivimab alone and in combination with etesevimab [see Adis Insight Drug profile 800058525]. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 3 300 patients in the US and Puerto Rico [45] . In September 2020, interim safety and efficacy results from the trial were released by the company [46] . In October 2020, the company released the interim analysis of the trial [25] . In January and March 2021, the company released additional data from the trial. In March 2021, Eli Lilly and Company released efficacy and adverse events data from a phase II/III trial at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [27] [24] .

In August 2020, Eli Lilly completed a phase I trial that evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of bamlanivimab in patients with COVID-2019 infections (17823; J2W-MC-PYAA; NCT04411628). The randomised, double-blind placebo-controlled trial was initiated in May 2020 and enrolled approximately 24 patients in the US [47] . As of July 2020, dosing has been completed in the trial. In September 2020, Eli Lilly has successfully completed enrollment in the trial and primary safety assessments of LY CoV 555 [46] [48] [49] .

In December 2020, Eli Lilly and Company completed a phase I trial that evaluated the pharmacokinetics, safety, and tolerability of bamlanivimab, administered subcutaneously in healthy volunteers (NCT04537910; 18124; J2X-MC-PYAG). The randomised, placebo-controlled, double-blind study was initiated in September 2020,and enrolled approximately 25 volunteers in the US [50] .

In April 2021, AbCellera reported results from the preclinical studies [51] .

As of March 2020, early research development for COVID-2019 treatment is underway in Canada [13] .

In October 2020, Eli Lilly and Company entered into an agreement with Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, to provide access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19 infections, to benefit low and middle-income countries [52] .

In preclinical studies, all resistant viruses, except the Q493R variant were neutralised by bamlanivimab and etesevimab [see Adis Insight Drug profile 800058525] combination therapy. Neutralisation and binding assessments also confirmed reduced susceptibility of the variants to the single selecting mAb with 50-fold or greater reductions in potency [53] .

Supply agreements

In February 2021, Junshi Biosciences and Eli Lilly and Company entered into a supply agreement with the US government for purchase of minimum of 100,000 doses of etesevimab (JS016 or LY-CoV016) 1400 mg [see Adis Insight Drug profile800058525] and bamlanivimab (LY-CoV555) 700 mg together. The agreement is for $210 million and 450,000 doses will be delivered through March 31, 2021. The U.S. government will have the option to purchase up to an additional 1,100,000 doses through November 25, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability and the medical need in the US [6] [5] .

In October 2020, Eli Lilly and Company entered into a supply agreement with the US government to meet Operation Warp Speed goals. As per agreement Lilly will supply 300,000 vials of bamlanivimab 700mg for COVID-19 for $US375 million. The initial agreement is for delivery over the two months following an Emergency Use Authorization (EUA) by the US Food and Drug Administration and also provides the option for the US government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability and the medical need in the US. Lilly is partnering with Operation Warp Speed and a national distributor to finalise distribution plans and shipping preparations. Lilly is also working with Operation Warp Speed to assist US federal and state agencies in the identification and creation of options for locations where patients can receive this medication that are accessible and minimise infection transmission [54] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Infusion, Injection
  • Class Antivirals, Monoclonal antibodies
  • Target Coronavirus spike glycoprotein; Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

  • CAS Registry Number 2423943-37-5

Biomarker

Drug Name Biomarker Name Biomarker Function
Bamlanivimab - Abcellera/Eli Lilly and Company C-reactive protein (CRP) Outcome Measure
Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10) Outcome Measure
CXCL13 Outcome Measure
Interleukin 1 alpha (IL-1α) Outcome Measure
Interleukin 1 Beta (IL-1β) Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-15 (IL-15) Outcome Measure
Interleukin-18 (IL-18) Outcome Measure
Interleukin-6 (IL-6) Outcome Measure
Interleukin-7 (IL-7) Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
MIP-1 alpha Outcome Measure
Monocyte chemoattractant protein-1 (MCP-1/CCL2) Outcome Measure
T-Cell differentiation antigen CD8 Eligibility Criteria, Outcome Measure
T-cell surface antigen CD4 Eligibility Criteria, Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections For bamlanivimab and etesevimab combination Combination therapy Registered Italy IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections emergency use authorisation Monotherapy Registered Kuwait, Panama IV / Infusion Abcellera, Eli Lilly and Company 10 Mar 2021
COVID 2019 infections Approved under EUA Approved under EUA; with Bill & Melinda Gates Foundation Approved under EUA, with Bill & Melinda Gates Foundation In adolescents, In adults, In children, In the elderly, Monotherapy Registered Czech Republic, Germany, Hungary, Israel, Italy, Morocco, Rwanda, Sweden, United Arab Emirates IV / Infusion Eli Lilly and Company 05 Mar 2021
COVID 2019 infections approved under emergency use authorization; in combination with etesevimab Combination therapy, In adults, In the elderly, Prevention Registered USA IV / Injection Abcellera, National Institute of Allergy and Infectious Diseases, Eli Lilly and Company 16 Sep 2021
COVID 2019 infections in combination with JS 016 (LY-CoV016) Combination therapy, In adolescents, In adults, In the elderly Registered USA IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections interim authorisation in individuals aged 12 years and older In adolescents, In adults, In children, In the elderly Registered Canada IV / Injection Abcellera, Eli Lilly and Company 20 Nov 2020
COVID 2019 infections Rolling review in EU for bamlanivimab and etesevimab combination Combination therapy, In adolescents, In adults, In children, In the elderly Preregistration European Union IV / Infusion Abcellera, Eli Lilly and Company 04 Feb 2021
COVID 2019 infections rolling review in EU In adolescents, In adults, In children, In the elderly, Monotherapy Preregistration European Union IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections being utilised under emergency use authorisation In adolescents, In adults, In children, In the elderly, Monotherapy Preregistration USA IV / Injection Abcellera, Eli Lilly and Company 07 Oct 2020
COVID 2019 infections with standard of care drug remdesivir Combination therapy, In adults, In the elderly Phase III USA IV / Infusion National Institute of Allergy and Infectious Diseases 04 Aug 2020
COVID 2019 infections - Combination therapy Phase III Denmark, Greece, Poland, Singapore, Spain, Sweden, Switzerland, USA, Uganda, United Kingdom IV / Infusion Eli Lilly and Company 13 Jun 2021
COVID 2019 infections - In adults, In the elderly Phase II/III Puerto Rico, USA IV / Infusion Eli Lilly and Company 19 Aug 2020
COVID 2019 infections in combination with etesevimab Combination therapy, In adults Phase II Argentina, Puerto Rico IV / Infusion Eli Lilly and Company 19 Jul 2021
COVID 2019 infections - In adults, Monotherapy Phase II Argentina, Puerto Rico IV / Infusion Eli Lilly and Company 19 Jul 2021
COVID 2019 infections - In adults, In volunteers Phase I USA SC / Injection Eli Lilly and Company 02 Sep 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Abcellera Originator Canada
Eli Lilly and Company Originator USA
Eli Lilly and Company Owner USA
Abcellera Owner Canada
Bill & Melinda Gates Foundation Funder USA
GlaxoSmithKline Collaborator United-Kingdom
Vir Biotechnology Collaborator USA
Sanford Burnham Prebys Medical Discovery Institute Collaborator USA
Shanghai Junshi Biosciences Collaborator China
National Institute of Allergy and Infectious Diseases Collaborator USA
UnitedHealth Group Collaborator USA

Scientific Summary

  • Adverse Events Occasional: Diarrhoea; Dizziness; Headache; Nausea; Pruritus; Vomiting

Adverse Events

Treatment with bamlanivimab in combination with etesevimab in the phase III portion of phasse II/III BLAZE-1 trial resulted in no deaths being reported in the treatment group. All deaths (10, of which eight were designated COVID-19 related) were reported only in placebo group. Between placebo (60/517,11.6%) and treatment group (69/518,13.3%), similar rates of adverse events were oberved. Interim analysis of the randomised, double-blind, placebo-controlled, phase II/III BLAZE-1 trial in patients with COVID-19 infections showed that combination therapy of bamlanivimab (LY CoV555) and etesevimab (LY CoV016) was generally well tolerated and safety profile was consistent with observations from other phase I, phase II and phase III trials. Serious adverse events were reported at a similar frequency in the etesevimab and bamlanivimab together and placebo groups. No drug-related serious adverse events were reported. In bamlanivimab monotherapy studies, isolated drug-related infusion reactions or hypersensitivity were observed that were generally mild (two reported as serious infusion reactions, all patients recovered). Treatment emergent adverse events were comparable to placebo for both bamlanivimab monotherapy and combination therapy. Earlier results showed that adverse events reported in at least 1% of participants on bamlanivimab 700 mg and placebo were nausea (3% vs 4%), diarrhoea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%) [27] [24] [25] [46] [26] [45] .

Bamlanivimab was safe and well tolerated in phase III BLAZE-2 trial in patients with COVID-2019 infections. Serious adverse events of similar frequency were reported in both placebo and bamlanivimab groups, as observed in phase I and phase II trials. No COVID-2019 related deaths were reported with bamlanivimab treatment. Of the 16 deaths reported, five were COVID-19 related and were from placebo group [39] [38] [36] .

In the phase II BLAZE-4 trial combination of bamlanivimab, 700mg with sotrovimab, 500mg was well tolerated without any serious adverse events in patients with COVID-2019 patients [44] [43] .

Pharmacodynamics

In preclinical studies, bamlanivimab neutralised SARS-CoV-2 by binding both the up and down confirmations of the spike receptor-binding domain (RBD) and inhibiting critical interactions with the angiotensin converting enzyme 2 (ACE2) cellular receptor necessary for viral entry. Prophylactic treatment with bamlanivimab resulted in significant decreases in viral load and replication in the upper and lower respiratory tracts after SARS-CoV-2 exposure, indicating the potential of bamlanivimab to reduce viral shedding and transmission [51] .

Therapeutic Trials

In the phase III portion of phase II/III BLAZE-1 trial, treatment with bamlanivimab in combination with etesevimab reduced COVID-19-related hospitalisations and deaths by 87% in high-risk patients recently diagnosed with COVID-19 versus placebo (p<0.0001). By Day 29, 70% of reduction in COVID-19 related hospitalisation and death by any cause was observed compared to placebo group (36/517 arm total) ([95% CI]=-4.8[-7.4,-2.3])(p=0.0004). Compared to placebo, a significant reduction in log 10 (viral load) was observed from the baseline at day seven in treatment group ([95% CI]=-1.20[-1.46,-0.94])(p<0.00000001). For those who received combination treatment (days [95% CI]=8[7.0,8.0]), the median time to sustained symptom resolution was shorter compared to those who received placebo (days [95% CI]=9[8.0,10.0])(p=0.007). Interim analysis of the phase II/III BLAZE-1 trial showed that combination therapy of bamlanivimab (LY CoV555) and etesevimab (LY CoV016) reduced viral load, symptoms and COVID-related hospitalisation and ER visits in patients recently diagnosed with mild to moderate COVID-19. Across 1 035 patients, there were 11 events (2.1%) in patients taking therapy and 36 events (7%) in patients taking placebo, representing a 70% risk reduction (p = 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking etesevimab and bamlanivimab together. The combination therapy significantly reduced viral load at day 11 (p = 0.011), met the primary and secondary endpoint endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. The combination treatment reduced viral levels at day 3 (p = 0.016) and day 7 (p < 0.001). Combination therapy also significantly reduced the time-weighted average change from baseline from day 1 to 11. The combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11 (p = 0.009). The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with bamlanivimab monotherapy. The rate of COVID-related hospitalisation and ER visits was lower for patients treated with combination therapy (0.9%) versus placebo (5.8%) a relative risk reduction of 84.5% (p = 0.049). This was also similar to observations for bamlanivimab monotherapy. An exploratory analysis showed that the proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3%) versus placebo (20.8%), corresponding to a nominal p value of p < 0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed in patients treated with combination therapy. Earlier results showed that the prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2 800 mg dose level, but not the others. The endpoint was met in 1.7% (5/302) of bamlanivimab patients, pooled across dose groups, as compared to 6% (9/150) of placebo patient corresponding to 72% risk reduction in this limited population. Additional analyses of viral data demonstrated that bamlanivimab improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points. Bamlanivimab demonstrated a direct antiviral effect against SARS-CoV-2 [55] [27] [24] [25] [46] [45] .

Results from phase III trial showed that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. Bamlanivimab 2800 mg and etesevimab 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19 by 70 percent, meeting the primary endpoint of the trial. Results from phase III BLAZE-2 trial receiving bamlanivimab at 8 weeks of follow up, demonstrated significantly lower frequency of symptomatic COVID-2019 (the primary endpoint) when compared with placebo (odds ratio 0.43, p = 0.00021). Bamlanivimab also resulted in reduction in risk of contracting COVID-19 by up to 80% in residents versus placebo (odds ratio 0.20; p = 0.00026). In additional, all key secondary endpoints also reached statistical significance in both the overall and resident populations. By day 57, the proportion of residents in the prevention population, who had mild to worse COVID-19 symptoms, were reported to be lower in the treatment group of bamlanivimab compared to the placebo group (odds ratio [OR], 0.20; 95% confidence interval [CI], 0.08 to 0.49; p<0.001). A significant reduction was observed in the incidence of moderate or worse COVID-19 by day 57 in the same group (OR, 0.20; 95% CI, 0.08 to 0.49; p<0.001) as well as in the incident SARS-CoV-2 infection by day 29 (OR, 0.23; CI, 0.11 to 0.48; p<0.001) compared with placebo [39] [40] [37] [38] [36] .

The phase II BLAZE-4 trial met primary endpoint in which combination of bamlanivimab, 700mg with sotrovimab, 500mg showed relative reduction in high viral load by 70% (> 5.27; cycle threshold value < 27.5) at day 7 compared with placebo (p < 0.001). The combination also led statistically significant reduction in mean SARS-CoV-2 viral load from baseline to days 3, 5 and 7 which was secondary endpoint of the trial. The combination therapy resulted in prolong survival and there were no report of COVID-19 related hospitalisation or death by day 29. One patient (in the treatment arm) required visit to the emergency room for COVID-19 related symptoms [44] [43] .

Future Events

Expected Date Event Type Description Updated
30 Nov 2020 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) to US FDA for COVID-2019 infections (Combination therapy) in November 2020 [25] 28 Jan 2021
31 Oct 2020 Trial Update Eli Lilly and Company plans a large open-label pragmatic clinical trial for COVID-2019 infections (Combination therapy, Monotherapy) in October 2020 (700328570) [25] 03 Dec 2020

Development History

Event Date Update Type Comment
16 Sep 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy, In the elderly, Prevention, In adults) in USA (IV) [23] Updated 21 Sep 2021
05 Sep 2021 Trial Update Eli Lilly completes enrolment in the phase II BLAZE-4 trial for COVID-2019 infections (In adults, Combination therapy) in Argentina, Puerto Rico and USA (IV, infusion) (NCT04634409) [1] Updated 23 Sep 2021
05 Sep 2021 Trial Update Eli Lilly completes enrolment in the phase II BLAZE-4 trial for COVID-2019 infections (In adults, Monotherapy) in Argentina, Puerto Rico and USA (IV, infusion) (NCT04634409) [1] Updated 23 Sep 2021
19 Jul 2021 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in Argentina (IV) (NCT04634409) Updated 23 Sep 2021
19 Jul 2021 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Monotherapy) in Argentina (IV) (NCT04634409) Updated 23 Sep 2021
29 Jun 2021 Trial Update Eli Lilly and Company in collaboration with AbCellera Biologics completes a phase II BLAZE-5 trial in COVID-2019 infections (In children, In adolescents, In adults, In the elderly) in USA (IV) (NCT04701658 (700332416) Updated 13 Jul 2021
26 May 2021 Biomarker Update Biomarkers information updated Updated 17 Sep 2021
20 May 2021 Trial Update Eli Lilly and Company completes a BLAZE-2 phase III trial for COVID-2019 infections (Prevention, In adults, In elderly, Combination therapy) in USA (NCT04497987) [34] Updated 18 Jun 2021
20 May 2021 Trial Update Eli Lilly and Company completes a BLAZE-2 phase III trial for COVID-2019 infections (Prevention, In adults, In elderly, Monotherapy) in USA (NCT04497987) [34] Updated 18 Jun 2021
18 Apr 2021 Regulatory Status US FDA revokes the emergency use authorization for COVID-2019 infections (In children, In adolescents, In adults, In the elderly, Monotherapy) in USA [19] Updated 23 Apr 2021
16 Apr 2021 Regulatory Status Eli Lilly and Company requests revocation of the emergency use authorization (EUA) for COVID-2019 infections (In Children, In adolescents, In adults, In the elderly, Monotherapy) in USA [20] Updated 20 Apr 2021
07 Apr 2021 Scientific Update Pharmacodynamics data from preclinical studies in COVID-2019 infections released by AbCellera [51] Updated 07 Apr 2021
29 Mar 2021 Scientific Update Efficacy and adverse events data from the phase II BLAZE-4 trial in COVID-2019 infections released by Eli Lilly and Company [44] Updated 31 Mar 2021
10 Mar 2021 Phase Change - Registered Registered (emergency use authorisation) for COVID-2019 infections (Monotherapy) in Panama, Kuwait (IV) [27] Updated 15 Mar 2021
10 Mar 2021 Scientific Update Updated efficacy and adverse events data from a phase II/III BLAZE-1 trial in COVID-2019 infections released by Abcellera [27] Updated 15 Mar 2021
06 Mar 2021 Scientific Update Adverse events and efficacy data from a phase III BLAZE-2 trial in COVID-2019 infections presented at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [39] Updated 26 Apr 2021
06 Mar 2021 Scientific Update Efficacy and adverse events data from a phase II/III BLAZE-1 trial in COVID-2019 infections presented at the 28th Conference on Retroviruses and Opportunistic Infections (CROI-2021) [55] Updated 24 Apr 2021
05 Mar 2021 Phase Change - Registered Registered for COVID-2019 infections (Monotherapy, In adolescents, In adults, In children, In the elderly) in Rwanda, Morocco, Czech Republic, Germany, Israel, Italy, Hungary, Sweden, United Arab Emirates (IV) under emergency authorisation before March 2021 [28] Updated 11 Mar 2021
05 Mar 2021 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) of the EMA issues positive opinion for bamlanivimab for COVID-2019 infections (Monotherapy, Combination therapy, In children, In adolescents, In adults, In the elderly) in European Union [16] Updated 09 Mar 2021
09 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy) in Italy (IV) [17] Updated 11 Feb 2021
09 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy, In adolescents, In the elderly, In adults) in USA (IV) [17] Updated 11 Feb 2021
09 Feb 2021 Regulatory Status The US FDA authorizes shortened infusion times for bamlanivimab alone and in combination with etesevimab [17] Updated 11 Feb 2021
09 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Monotherapy, In children, In adolescents, In adults, In the elderly) in European Union [18] Updated 09 Feb 2021
04 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Combination therapy, In children, In adolescents, In adults, In the elderly) in European Union [18] Updated 09 Feb 2021
01 Feb 2021 Trial Update Eli Lilly and Company in collaboration with AbCellera Biologics initiates the phase II BLAZE-5 trial in COVID-2019 infections (In children, In adolescents, In adults, In the elderly) in USA (IV) (NCT04701658 (700332416) Updated 05 Mar 2021
29 Jan 2021 Scientific Update Efficacy data from a phase III trial in COVID-2019 infections released by Eli Lilly and Company [40] Updated 02 Feb 2021
27 Jan 2021 Licensing Status Eli Lilly, Vir Biotechnology and GlaxoSmithKline entered an agreement to evaluate bamlanivimab in combination with sotrovimab for COVID-2019 infections [8] Updated 29 Jan 2021
26 Jan 2021 Scientific Update Updated efficacy and adverse events data from a phase II/III BLAZE-1 trial in COVID-2019 infections released by Junshi Biosciences [24] Updated 28 Jan 2021
22 Jan 2021 Scientific Update Adverse events and efficacy data from a phase III trial in COVID-2019 infections released by AbCellera [38] Updated 25 Jan 2021
21 Jan 2021 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) for COVID-2019 infections (Prevention) [37] Updated 25 Jan 2021
21 Jan 2021 Scientific Update Efficacy data from the phase III BLAZE-2 trial in COVID-2019 infections released by Eli Lilly and Company [37] Updated 25 Jan 2021
08 Jan 2021 Trial Update Eli Lilly and Company and AbCellera Biologics plan the phase II BLAZE-5 trial for mild-to-moderate COVID-2019 infections (In children, In adolescents, In adults, In the elderly) (IV) (NCT04701658) Updated 12 Jan 2021
28 Dec 2020 Trial Update Eli Lilly and Company completes a phase I trial in COVID-2019 infections (In volunteers, In adults) in USA (SC) (NCT04537910) Updated 01 Feb 2021
04 Dec 2020 Licensing Status Eli Lilly and Company and UnitedHealth Group collaborate to diagnose and treat COVID-2019 infection with in-home bamlanivimab treatment in USA [9] Updated 10 Dec 2020
04 Dec 2020 Trial Update Eli Lilly and Company and UnitedHealth Group initiate the UNITED trial for COVID-2019 infections in USA (IV) [9] Updated 10 Dec 2020
02 Dec 2020 Licensing Status Bamlanivimab licensed to the US government for the treatment of COVID-2019 infections [2] Updated 10 Dec 2020
30 Nov 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Combination therapy, In adolescents, In the elderly, In adults) in USA (IV) [24] Updated 28 Jan 2021
30 Nov 2020 Regulatory Status Eli Lilly and Company files request for emergency use authorization (EUA) for COVID-2019 infections (In Children, In adolescents, In adults, In the elderly, Combination therapy) in USA [24] Updated 28 Jan 2021
20 Nov 2020 Phase Change - Registered Registered (interim authorisation) for COVID-2019 infections (In adolescents, In children, In the elderly, In adults) in Canada (IV, injection) [26] Updated 16 Dec 2020
20 Nov 2020 Regulatory Status Lilly was in discussions with regulators from India, Brazil, Russia and Europe for authorisation of bamlanivimab for COVID-2019 infections before November 2020 [26] Updated 24 Nov 2020
20 Nov 2020 Scientific Update Adverse events data from phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [26] Updated 24 Nov 2020
19 Nov 2020 Trial Update Eli Lilly and company completes an expanded-access programme for COVID-2019 infections in US (NCT04603651) Updated 03 Dec 2020
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in Puerto Rico (IV) (NCT04634409) after October 2020 [42] Updated 28 Jan 2021
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Monotherapy) in Puerto Rico (IV) (NCT04634409) after October 2020 [42] Updated 28 Jan 2021
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in USA (IV, infusion) (NCT04634409) Updated 03 Dec 2020
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Monotherapy) in USA (IV, infusion) (NCT04634409) Updated 03 Dec 2020
28 Oct 2020 Regulatory Status Bamlanivimab is part of Operation Warp Speed for COVID-2019 infections [54] Updated 30 Oct 2020
27 Oct 2020 Trial Update Eli Lilly initiates an expanded access programme in COVID-2019 infections in USA (NCT04603651) Updated 30 Oct 2020
14 Oct 2020 Trial Update Eli Lilly and Company suspends enrolment in its ongoing phase III TICO (ACTIV-3) trial in COVID-2019 infections in USA due to DSMB recommendation [33] Updated 19 Oct 2020
08 Oct 2020 Company Involvement Eli Lilly and Company enters into a COVID-19 Therapeutics Accelerator program with Bill & Melinda Gates Foundation for COVID-2019 infections [52] Updated 09 Nov 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) to US FDA for COVID-2019 infections (Combination therapy) in November 2020 [25] Updated 28 Jan 2021
07 Oct 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (In adolescents, In children, In the elderly, Monotherapy, In adults) in USA (IV, injection) before October 2020 [25] Updated 16 Dec 2020
07 Oct 2020 Trial Update Eli Lilly and Company plans a large open-label pragmatic clinical trial for COVID-2019 infections (Combination therapy, Monotherapy) in October 2020 [25] Updated 03 Dec 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company announces intention to submit biologics license application (BLA) to US FDA for COVID-2019 infections (Combination therapy) [25] Updated 13 Oct 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company files initial request for emergency use authorization (EUA) for COVID-2019 infections in USA before October 2020 [25] Updated 13 Oct 2020
07 Oct 2020 Scientific Update Interim efficacy and adverse events data from a phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [25] Updated 13 Oct 2020
16 Sep 2020 Scientific Update Interim safety and efficacy data from the phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [46] Updated 18 Sep 2020
16 Sep 2020 Trial Update Eli Lilly and Company completes enrolment in its phase I trial for COVID-2019 infections in USA (IV, injection) (NCT04411628) [46] Updated 18 Sep 2020
07 Sep 2020 Trial Update Eli Lilly and Company plans a phase I pharmacokinetics trial (In volunteers) in USA (NCT04537910) Updated 07 Sep 2020
02 Sep 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In volunteers, In adults) in USA (SC) (NCT04537910) Updated 16 Dec 2020
26 Aug 2020 Trial Update Eli Lilly and Company completes a phase I trial for COVID-2019 infections in USA (IV, injection) (NCT04411628) Updated 23 Sep 2020
19 Aug 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In adults, In the elderly) in USA, Puerto Rico (IV, infusion) (NCT04518410) Updated 16 Dec 2020
04 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy) in Singapore, Denmark, Spain, Switzerland, Sweden, Greece, United Kingdom, USA, Uganad, Poland (IV) (NCT04501978) (EudraCT2020-003278-37) Updated 21 Jun 2021
04 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy, In adults, In the elderly) in USA (IV, infusion) (NCT04501978) Updated 10 Aug 2020
03 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in USA (IV, injection) [35] (NCT04497987) Updated 05 Aug 2020
02 Aug 2020 Trial Update Eli Lilly and Company initiates enrolment in the BLAZE-2 phase III trial for COVID-2019 infections (Prevention, In adults, In elderly, Monotherapy) in USA (NCT04497987) [34] Updated 18 Jun 2021
02 Aug 2020 Trial Update Eli Lilly and Company initiates enrolment in the BLAZE-2 phase III trial for COVID-2019 infections (Prevention, In adults, In elderly, Combination therapy) in USA (NCT04497987) [34] Updated 18 Aug 2020
01 Jul 2020 Licensing Status Sanford Burnham Prebys Medical Discovery Institute enters into an research agreement with Eli Lilly and Company to characterise Lilly’s next-generation anti-SARS-CoV-2 antibodies [12] Updated 07 Jul 2020
17 Jun 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In the elderly, In adults, In adolescents, In children, Combination therapy) in USA (IV, injection) (NCT04427501) [46] Updated 18 Sep 2020
17 Jun 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In the elderly, In adults, In adolescents, Monotherapy) in USA (IV, injection) (NCT04427501) Updated 25 Jun 2020
01 Jun 2020 Trial Update Eli Lilly and AbCellera plan a phase II trial in COVID-2019 infections (IV) [49] Updated 05 Jun 2020
28 May 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In adults, In the elderly) in USA (IV, injection) [49] (NCT04411628) Updated 05 Jun 2020
12 Mar 2020 Licensing Status Abcellera and Eli lilly and Company agree co-develop Coronavirus neutralizing antibodies for COVID-19 infections [13] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in Canada (IV) [13] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (IV) [13] Updated 05 Jun 2020
17 Nov 2019 Trial Update Eli Lilly initiates a phase-II/III trial in COVID-2019 infections (In the elderly, In adults, In adolescents, In children, Combination therapy) in Puerto Rico (IV, injection) (NCT04427501) Updated 25 Jan 2021

References

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