Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline Plc (NYSE:GSK) have announced the expansion of the global Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent of Care Early) trial. The study evaluates VIR-7831 in the early treatment of patients with COVID-19 whose risk of hospitalization is high.
Vir and GSK expand phase 3 COMET-ICE study globally
VIR-7831, also called GSK4182136, is a fully human anti-SARS-CoV-2 monoclonal antibody that can neutralize the coronavirus and offers a higher barrier to resistance. The antibody can potentially kill the virus and help in achieving high concentrations in the lungs. After encouraging the assessment of unblinded safety results from the lead-in part of the study by the Independent Data Monitoring Committee at the end of September, the company will expand the COMET-ICE trial globally.
VIR CEO George Scangos said that the quick achievement of such a huge milestone shows the urgency with which the company is mobilizing resources to prevent the consequences of SARS-CoV-2. Scangos stated that VIR-7831 is an antibody with the potential of preventing COVID-19 hospitalizations and possibly death through multiple mechanisms. He added that they will continue partnering with GlaxoSmithKline in accelerating the development of VIR-7831.
VIR-7831 Study results expected at the end of the year
On the other hand, GSK R&D president and chief scientific officer Dr. Hal Barron said that considering the urgent patient needs, they are pleased to have advanced development of VIR-7831 from pre-clinical trials to third phase study in six months since the signing of collaboration with Vir. Hal added that they are optimistic that the neutralizing antibody’s notable effector function, high barrier to resistance as well as enhanced delivery into lungs shows its best-in-class potential in fighting the global COVID-19 pandemic.
The third phase part of the COMET-ICE study will evaluate the efficacy and safety of singer VIR-7831 intravenous infusion or placebo in around 1,300 non-hospitalized subjects globally. Preliminary analysis will evaluate the antibody’s futility, safety, and efficacy, with results expected at the end of this year. The primary efficacy endpoint results will be realized in Q1 2021.