Vir Biotechnology, GlaxoSmithKline Expand to Phase 3 Study of Treatment for Covid-19

By Robb M. Stewart

Vir Biotechnology Inc. and GlaxoSmithKline PLC are expanding to a late-stage global trial their study of an early treatment of Covid-19 in patients who are at high risk of hospitalization.

The companies said Tuesday they are moving to Phase 3 their monoclonal antibody efficacy trial evaluating VIR-7831, a fully human anti-SARS-CoV-2 antibody selected based on its potential to neutralize the virus, kill infected cells, provide a barrier to resistance and achieve high concentrations in the lungs.

Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an independent data monitoring committee on Sept. 30, the study will now expand globally to additional sites in North America, South America and Europe.

Vir's shares are poised for a strong open on the back of the expanded study, rising 18% in premarket trading after closing Monday at $39.11.

Patient enrollment is underway and Vir and GlaxoSmithKline said initial Phase 3 results could be available as early as the end of the year. Results for the primary endpoint are expected in the first quarter of 2021, with a current target of January, they said.

The Phase 3 portion of the study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in about 1,300 non-hospitalized participants globally, split between patients in the treatment arm and the placebo arm. The primary efficacy 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, the companies said.

A clinical development program for VIR-7831 will include two additional planned trials, one for the treatment of hospitalized patients and another for the prevention of symptomatic infection.

The companies said they expect to start a Phase 1b/2a trial in the second half of the year evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

October 06, 2020 09:01 ET (13:01 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.