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Vir/GSK Move Lead Coronavirus Antibody Into Phase III

Safety In 20 Phase II Patients Enabled Testing In 1,300 People

 
• By Mandy Jackson

Results from a Phase II/III study for VIR-7831 in the prevention of hospitalization due to COVID-19 are expected in late 2020 and early 2021.

Immunological system, antibodies attacking the virus covid-19. 3D illustration, concept of the body's defense system. Y-shaped antibody attacking the coronavirus.
VIR-7831 is engineered to neutralize SARS-CoV-2, with limited treatment resistance, enhanced lung bioavailability and an extended half-life • Source: Shutterstock

Vir Biotechnology, Inc. and GlaxoSmithKline plc are taking VIR-7831 (GSK4182136) – an antibody therapy against SARS-CoV-2 – into Phase III testing based on safety results from the Phase II lead-in to the Phase II/III COMET-ICE clinical trial. Initial data from the registrational Phase III portion of the trial seeking to prevent hospitalization of COVID-19 patients may be available before the end of 2020 with complete results expected in January 2021, the companies said on 6 October.

Vir chief medical officer Phil Pang told Scrip that the COMET-ICE independent data monitoring committee reviewed safety data from 20 US patients – 10 who were treated with VIR-7831 and 10 who received a placebo – and found that the results justified moving into Phase III

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