Vir Biotechnology, Inc. and GlaxoSmithKline plc today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs (one of the major sites of infection).

ACTIV-3 is one of several ongoing trials in the NIH’s ACTIV program, an NIH-led public-private partnership designed to accelerate the development of the most promising treatments and vaccine candidates for COVID-19. ACTIV-3 has been designed as a “master protocol” that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, but within the same clinical trial structure, across multiple trial sites.

George Scangos, Ph.D., Chief Executive Officer of Vir, said: “Recent data suggest that the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19. We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future.”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “With new infection and hospitalization rates reaching record highs, the world needs multiple options to help combat this pandemic. We are developing solutions to fight this virus, from prevention through treatment, to provide relief from COVID-related illness. Our treatment option, VIR-7831, which has a high barrier to resistance and has the potential to neutralize the virus and kill infected cells, could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact.”

In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization. The Phase 3 part of the COMET-ICE trial is assessing the safety and efficacy of a single intravenous (IV) infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of adults who have a progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. The COMET clinical development program for VIR-7831 also includes a planned Phase 3 trial for the prevention of symptomatic infection.