COVID-19 Monotherapy Study Stopped 'Due to Evidence of Profound Efficacy'
California-based Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 (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, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo.
As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.
Based on these results, Vir and GSK plan to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) and other countries' authorizations. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.
The companies also announced today 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. In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, making it more difficult for resistance to develop.
Dr. Hal Barron, chief scientific officer, and president of R&D, GSK, commented in a related press statement, “We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings.”
Vir Biotechnology is a clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.