October 06, 2020: “Vir Biotechnology, Inc. and GlaxoSmithKline plc 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.”