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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: 03 Dec 2020

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

  • Phase III COVID 2019 infections

Most Recent Events

  • 20 Nov 2020 Bamlanivimab received interim authorisation from Health Canada as a treatment for COVID-2019 infections
  • 20 Nov 2020 Lilly was in discussions with regulators from India, Brazil, Russia and Europe for authorisation of bamlanivimab for COVID-2019 infections before November 2020
  • 20 Nov 2020 Adverse events data from phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company

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. Late stage clinical development is underway in the US. Early research is ongoing in Canada.

Bamlanivimab is available in the US under emergency authorisation and in Canada under interim authorisation for COVID-2019 infections [1] .

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 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 [2]

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. [3]

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. [4]

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. [5] [6]

Key Development Milestones

In November 2020, AbCellera announced that bamlanivimab 700 mg has received 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] [7] . 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. The company intends to submit a subsequent request for EUA for bamlanivimab and etesevimab [see Adis Insight Drug profile 800053492] combination therapy, once additional safety data avanilability, pending clinical trial enrolment and sufficient supply is manufactured. The company also plans to file a biologics license application (BLA) submission for combination therapy [8] .

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, is based on data from BLAZE-1 trial [see below] [9] .

As of November 2020, Lilly was in discussions with global regulators including from India, Brazil, Russia and Europe for pursuing authorisation of bamlanivimab for COVID-2019 infections [9] .

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) [10] .

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 [11] .

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 [12] . In October 2020, Independent data safety monitoring board (DSMB) recommended to pause enrolment in its ongoing phase III trial [13] .

In August 2020, Eli Lilly, in collaboration with AbCellera Biologics and National Institute of Allergy and Infectious Diseases, initiated a phase III BLAZE-2 trial to evaluate bamlanivimab to prevent COVID-2019 infections (NCT04497987; 18063; J2X-MC-PYAD; CoVPN #3501). The randomised study will include up to 2,400 participants and assess the ability of bamlanivimab to prevent infection of long-term care residents and facility staff who have been exposed to SARS-CoV-2 in the US and is being 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 [14] [15] [16] .

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 enroll 500 patients in the US and planned to expand in Puerto Rico [17] .

In October 2020, the phase II BLAZE-1 trial met the primary endpoint of the study by significantly reducing viral load at day 11 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 800053492]. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 800 patients in the US [18] . In September 2020, interim safety and efficacy results from the trial were released by the company [19] . In October 2020, the company released the interim analysis of the trial [8] .

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 [20] . 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 [19] [21] [22] .

In September 2020, Eli Lilly and Company initiated a phase I trial to evaluate the pharmacokinetics, safety, and tolerability of bamlanivimab, administered subcutaneously in healthy volunteers (NCT04537910; 18124; J2X-MC-PYAG). The randomised, placebo-controlled, double-blind study intends to enrol approximately 27 participants in the US [23] .

As of March 2020, early research development for COVID-2019 treatment is underway in Canada [5] .

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 [24] .

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 [25] .

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation Infusion
  • 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

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Phase III USA IV / Infusion Abcellera, National Institute of Allergy and Infectious Diseases, Eli Lilly and Company 03 Aug 2020
COVID 2019 infections with standard of care drug remdesivir Combination therapy, In adults, In the elderly, Treatment-naive Phase III USA IV / Infusion National Institute of Allergy and Infectious Diseases 04 Aug 2020
COVID 2019 infections in combination with JS 016 (LY-CoV016) Combination therapy, In adolescents, In adults, In children, In the elderly Phase II USA IV / Infusion Abcellera, Eli Lilly and Company 17 Jun 2020
COVID 2019 infections in combination with LY 3832479(LY CoV016) Combination therapy, In adults Phase II USA IV / Infusion Eli Lilly and Company 29 Oct 2020
COVID 2019 infections being utilised under emergency use authorisation In adolescents, In adults, In children, In the elderly, Monotherapy Phase II USA IV / Infusion Abcellera, Eli Lilly and Company 17 Jun 2020
COVID 2019 infections - In adults, Monotherapy Phase II USA IV / Infusion Eli Lilly and Company 29 Oct 2020
COVID 2019 infections interim authorisation - Research Canada IV / Infusion Abcellera, Eli Lilly and Company 12 Mar 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
Sanford Burnham Prebys Medical Discovery Institute Collaborator USA
National Institute of Allergy and Infectious Diseases Collaborator USA

Scientific Summary

Adverse Events

Interim analysis of the randomised, double-blind, placebo-controlled, phase II 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. 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. Adverse events reported in at least 1% of BLAZE-1 clinical trial 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%) [8] [19] [9] [18] .

Therapeutic Trials

Interim analysis of the phase II 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. The combination therapy significantly reduced viral load at day 11 (p = 0.011), met the primary 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 [8] . 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 [19] [18] .

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 in November 2020 [8] 25 Nov 2020
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) [8] 03 Dec 2020

Development History

Event Date Update Type Comment
20 Nov 2020 Regulatory Status Bamlanivimab received interim authorisation from Health Canada as a treatment for COVID-2019 infections [9] Updated 24 Nov 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 [9] 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 [9] 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
09 Nov 2020 Regulatory Status Bamlanivimab received emergency use authorization from the US FDA for COVID-2019 infections (In adults, In the elderly, In children, In adolescents, Monotherapy) [7] Updated 11 Nov 2020
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in USA (IV) (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) (NCT04634409) Updated 03 Dec 2020
28 Oct 2020 Regulatory Status Bamlanivimab is part of Operation Warp Speed for COVID-2019 infections [25] 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 [13] 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 [24] Updated 09 Nov 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 [8] Updated 03 Dec 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 in November 2020 [8] Updated 25 Nov 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) [8] 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 [8] 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 [8] 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 [19] 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 (NCT04411628) [19] 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 Trial Update Eli Lilly and Company initiates a phase I pharmacokinetic trial (In volunteers, In adults) in USA (SC) (NCT04537910) Updated 29 Sep 2020
26 Aug 2020 Trial Update Eli Lilly and Company completes a phase I trial for COVID-2019 infections in USA (NCT04411628) Updated 23 Sep 2020
19 Aug 2020 Trial Update National Institute of Allergy and Infectious Diseases and Eli Lilly initiate the phase II/III Adapt Out COVID trial in COVID-2019 infections in USA (IV) (NCT04518410) Updated 24 Aug 2020
10 Aug 2020 Trial Update Eli Lilly and Company initiates enrolment in the BLAZE-2 phase III trial for COVID-2019 infections in USA (NCT04497987) [14] Updated 18 Aug 2020
04 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy, Treatment-naïve, In adults, In the elderly) in USA (IV) (NCT04501978) Updated 10 Aug 2020
03 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in USA (IV) [15] (NCT04497987) Updated 05 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 [4] Updated 07 Jul 2020
17 Jun 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In the elderly, In adults, In adolescents, In children, Combination therapy) in USA (IV) (NCT04427501) [19] 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) (NCT04427501) Updated 25 Jun 2020
01 Jun 2020 Trial Update Eli Lilly and AbCellera plan a phase II trial in COVID-2019 infections (IV) [22] 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) [22] (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 [5] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in Canada (IV) [5] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (IV) [5] Updated 05 Jun 2020

References

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    Media Release
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    ctiprofile
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