On Tuesday, Vir Biotechnology & GSK announced the COMET-ICE study evaluating VIR-7831, a fully human anti-SARS-CoV-2 monoclonal antibody, will continue into Phase 3 based on an Independent Data Monitoring Committee’s positive evaluation of safety and tolerability data from the Phase 2 lead-in. Initial study results may be available before the end of 2020 with complete results anticipated in January 2021. If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19.
Monoclonal antibodies are being investigated as a potential therapeutic and prophylactic approach against the disease. Vir’s antibody platform has identified unique antibodies from survivors that may work by blocking the virus from infecting new cells (neutralization) and by recruiting the immune system to eliminate infected cells (effector function).
George Scangos, Ph.D., chief executive officer of Vir, said: “The rapid achievement of this important milestone reflects the urgency with which we’re mobilizing 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 hospitalization 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 neutralizing 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-hospitalized 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 hospitalization or death within 29 days of randomization. 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 program for VIR-7831 includes two additional planned trials – one for the treatment of hospitalized patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in the second half of 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.
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