Vir Biotechnology and GSK announce start of NIH-sponsored ACTIV-3 trial evaluating VIR 7831 in hospitalised adults with COVID-19.

Vir Biotechnology, Inc. and GlaxoSmithKline plc 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 III clinical trial. This trial is designed to evaluate the safety and efficacy of VIR 7831 for the treatment of hospitalised adults with COVID-19. VIR 7831 (also known as GSK 4182136) 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 neutralise 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 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 neutralising activity of antibodies may be insufficient to protect hospitalised 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.” In addition to the Phase III ACTIV-3 trial, VIR 7831 is also being evaluated in the global Phase II/III 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 hospitalisation. The Phase III 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-hospitalised participants globally. The primary efficacy endpoint is the proportion of adults who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation. The COMET clinical development program for VIR 7831 also includes a planned Phase III trial for the prevention of symptomatic infection. ACTIV-3 Clinical Trial Design: The ACTIV-3 trial arm evaluating VIR 7831 will initially compare 300 participants who have been hospitalised with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either VIR 7831 or placebo. Participants also will receive standard care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants’ clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. If the VIR 7831 treatment arm appears to have a positive benefit:risk profile, the trial will enrol an additional 700 participants, including those who are more severely ill (i.e., adults with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs). Trial participants will be followed for 90 days following enrolment to analyse their response to treatment. The primary efficacy endpoint is the participants’ sustained recovery for 14 days after release from the hospital.