GlaxoSmithKline (GSK) and Vir Biotechnology have announced that they will expand the study of a VIR-7831 (GSK4182136) monoclonal antibody to treat Covid-19.
The companies announced the global expansion to phase 3 of the Covid-19 monoclonal antibody efficacy trial – intent to care early (COMET-ICE) to assess VIR-7831 for the early treatment of Covid-19 in patients who are at high risk of hospitalisation.
VIR-7831 is a fully human antiSARS-CoV-2 monoclonal antibody, which was selected based on its potential capacity to neutralise the virus, kill infected cells, offer a high barrier to resistance, and achieve high concentrations in the lungs.
Both firms have decided to expand the COMET-ICE registrational study to additional sites in North America, South America and Europe based on a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee.
Vir Biotechnology CEO George Scangos said: “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.”
The COMET-ICE study’s phase 3 portion will evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in around 1,300 non-hospitalised participants across the globe.
GSK and Vir Biotechnology will recruit 670 patients in the treatment arm and up to 670 patients in the placebo arm.
According to GSK, the primary efficacy endpoint is the proportion of patients who have a progression of Covid-19 as defined by the need for hospitalisation or death within 29 days of randomisation.
Interim analyses are planned to assess safety, futility and efficacy. The results are set to be available by the end of this year. The primary endpoint results are expected to be available in the first quarter of 2021.
VIR-7831’s COMET clinical development programme comprises two additional trials, of which the first one is to treat hospitalised patients and another for the prevention of symptomatic infection.
In addition, the firms are planning to begin a phase 1b/2a trial by the end of this year to assess VIR-7832, a second investigational SARS-CoV-2 neutralising antibody.
In April this year, Vir and GSK have collaborated for the research and development of solutions for coronaviruses, including SARS-CoV-2.
GSK chief scientific officer and R&D president Dr Hal Barron 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”