Vir Biotechnology, GlaxoSmithKline Expand to Phase 3 Study of Treatment for Covid-19
07 October 2020 - 12:16AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
October 06, 2020 09:01 ET (13:01 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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