GlaxoSmithKline and Vir’s Monoclonal Antibody Enters Phase 3 COVID-19 Trials

GlaxoSmithKline (GSK) and Vir Biotechnology have begun enrolling participants in phase 3 trials to assess the safety and efficacy of their monoclonal antibody, VIR-7831, in treating COVID-19 infections early on in high-risk patients.

The late-stage trials in North America, South America and Europe will assess a single intravenous infusion of the antibody vs. a placebo in approximately 1,300 nonhospitalized patients to see if the treatment can prevent hospitalization or death within 29 days.

Interim trial results could be ready by end of this year, but the complete results won’t be available until the first quarter of 2021, the companies said. The partners advanced the candidate treatment to late-stage trials based on positive safety and tolerability data from a phase 2 study.

President Trump, who announced last week that he and the first lady had contracted COVID-19, is currently being treated with another antibody therapy in phase 3 trials, Regeneron’s REGN-COV2. The president is also receiving Gilead Sciences’ antiviral remdesivir and the corticosteroid dexamethasone (DID, Oct. 5). — James Miessler