The study evaluating the antibody therapy VIR-7831 (GSK4182136) for the early treatment of patients with coronavirus disease 2019 (COVID-19) has moved into phase 3, according to GlaxoSmithKline and Vir Biotechnology, Inc.
By binding to an epitope on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the fully human monoclonal antibody has been shown to neutralize the virus. The investigational treatment is expected to achieve high concentrations in the lungs and was designed to have an extended half-life.
The multicenter, double-blind, placebo-controlled phase 2/3 COMET-ICE study consists of 2 parts investigating VIR-7831 in non-hospitalized patients with mild to moderate COVID-19 who are at high risk of hospitalization. The first part assessed the safety and tolerability of VIR-7831 over a 14-day period. Following a positive assessment by an independent data monitoring committee, the trial will now expand globally to additional sites.
The second part of the study will assess the efficacy and safety of a single intravenous infusion of VIR-7831 in approximately 1300 patients. The primary efficacy end point will be the proportion of patients who have progression of COVID-19, defined as the need for hospitalization or death within 29 days of randomization.
Interim analyses are anticipated as early as the end of 2020; results for the primary end point are expected in the first quarter of 2021.
“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,” said Dr Hal Barron, Chief Scientific Officer and President R&D, GSK.
The Companies are also investigating VIR-7831 for the treatment of hospitalized COVID-19 patients and for the prevention of symptomatic infection.
Vir Biotechnology and GSK announce global expansion to phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19. [press release]. San Francisco, CA: GlaxoSmithKline; October 8, 2020.