Vir, GSK : VIR-7831 Reduces Hospitalization And Risk Of Death In Early Treatment Of COVID-19

(RTTNews) - Vir Biotechnology Inc. (VIR) and GlaxoSmithKline plc (GSK, GSK.L) said Wednesday that an Independent Data Monitoring Committee or IDMC recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 or GSK4182136 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy.

The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial. The trial demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo. VIR-7831 was well tolerated.

The companies plan to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration and for authorizations in other countries. Data from the registrational trial will also form the basis for a Biologics License Application submission to the FDA.

The companies also announced the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays.