Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm
of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while
VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns
about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature.
The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of
the still-emerging data.
The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.
George Scangos, Ph.D., chief executive officer of Vir, said: “While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients. We want to thank NIH for their work to assess the benefits of VIR-7831 and other agents, and look forward to working with them to further understand the potential of VIR-7831 to provide a benefit in this population. In addition, we are eagerly anticipating the upcoming data from the Phase 3 COMET-ICE trial in newly-diagnosed COVID-19 patients at high risk of hospitalization.”
Christopher Corsico, Senior Vice President Development, GSK, said: “We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally. These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic.”