Vir Biotechnology and GlaxoSmithKline (GSK) are set to conclude enrolment in a Phase III trial of VIR-7831 (GSK4182136) as a monotherapy for the early Covid-19 treatment in adults at high risk of hospitalisation.
An investigational dual-action SARS-CoV-2 monoclonal antibody, VIR-7831 demonstrated the potential to inhibit viral entry into healthy cells, as well as clear infected cells in preclinical studies.
The latest development comes after an Independent Data Monitoring Committee (IDMC) recommended stopping enrolment owing to evidence of profound efficacy.
Named ‘Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE)’, the multi-centre, double-blind, placebo-controlled trial is analysing the safety and efficacy of a single IV infusion of 500mg VIR-7831 or placebo.
It enrolled 1,300 non-hospitalised subjects in North America, as well as additional sites in South America and Europe.
The IDMC advice is based on an interim analysis of data from 583 subjects enrolled in the trial. It showed a reduction of 85% in hospitalisation or death in patients receiving VIR-7831 as a monotherapy versus placebo, meeting the trial’s primary endpoint.
Furthermore, the VIR-7831 treatment was well-tolerated.
Additional data, including epidemiology and virology results, will be reported on concluding the ongoing trial, which is following up the patients for 24 weeks.
Vir and GSK intend to seek an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and authorisations in other countries for the monotherapy on obtaining these results.
Vir CEO George Scangos said: “The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics.
“These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of Covid-19 and highlight its potential ability to protect against the current circulating strains of the virus.”