Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19
For media and investors only
Issued: London UK and San Francisco US
- Independent Data Monitoring Committee recommended on September 30, 2020 that the study continues into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in.
- Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021.
- If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19.
- Patient enrollment underway; website live at https://vircovid19study.com/
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. VIR-7831 (also known as GSK4182136) is a fully human antiSARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential ability to neutralise the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (the major site of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe.
George Scangos, Ph.D., Chief Executive Officer of Vir, said: “The rapid achievement of this important milestone reflects the urgency with which we’re mobilising our resources in the hope of preventing the worst consequences of this deadly virus. VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalisation or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development.”
Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Given the urgent patient need I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing our collaboration with Vir. We believe this neutralising antibody’s high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic.”
The Phase 3 portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalised participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation. Interim analyses are planned to evaluate safety, futility and efficacy, the results of which may be available as early as the end of 2020. Results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021.
The COMET clinical development programme for VIR-7831 includes two additional trials – one for the treatment of hospitalised patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in late 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralising antibody that shares the same characteristics as VIR-783, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.
About VIR-7831 / GSK4182136
VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralise SARSCoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.
VIR-7832 is a monoclonal antibody that has shown the ability to neutralise SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.
About the Vir and GSK Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.