Vir's COVID-19 Antibody Update: Vir said it is advancing VIR-7831 — a fully human anti-SARS-CoV-2 monoclonal antibody it is developing along with GlaxoSmithKline plc (NYSE:GSK) — into a global Phase 3 trial dubbed COMET-ICE.
The development follows recommendation by an independent data monitoring committee on Sept. 30 that the study continue into Phase 3 on the basis of a positive evaluation of safety and tolerability data from the Phase 2 study.
The registrational study will now expand globally into additional sites in North America, South America and Europe, according to Vir and GlaxoSmithKline.
Vir's Phase 3 Study Protocol: The Phase 3 portion will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally, the companies said.
The primary 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.
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What's Next For Vir, GlaxoSmithKline: Vir and GlaxoSmithKline expect initial Phase 3 results as early as the end of 2020.
Results for the primary endpoint are due in the first quarter of 2021, with current projections for January.
The COMET program will also include two additional trials: one to evaluate VIR-7831 in hospitalized patients, and another for the prevention of symptomatic infection.
The companies also said they expect to start a Phase 1b/2a trial evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody, in the second half of 2020.
VIR-7832, while sharing the same characteristics as VIR-7831, also has enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.
VIR, GSK Price Action: At last check, Vir shares were up 2.91% to $40.25, while GlaxoSmithKline was slipping 1.55% to $37.10.