Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) have announced the dosing of the first patients in the new National Institutes of Health’s sub trial of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Third Phase clinical study.
ACTIV-3 study evaluating safety and efficacy of VIR-7831
The companies have designed the study to evaluate VIR-7831’s safety and efficacy in treating hospitalized COVID-19 patients. VIR-7831 which is also known as GSK4182136 is a fully human anti-SARS-CoV-2 experimental monoclonal antibody picked based on its potential of neutralizing the COVID-19 virus, kill infected cells, provide high concentrations in the lungs, and a barrier to resistance.
ACTIV-3 is among the numerous on-going studies in the NIH’s ACTIV program, which is a private-public partnership led by NIH designed to expedite developing promising treatments and vaccines for COVID-19. ACTIV-3 is designed as a “master protocol” allowing simultaneous evaluation of several experimental therapies as they become available, albeit within a similar clinical study stricture in various trial sites.
Vir CEO, George Scangos said that the recent data shows that antibodies’ neutralizing activity could be insufficient in protecting hospitalized adults from severe consequences of SARS-CoV-2. He added that they are optimistic that VIR-7831’s differentiating factors and wide anti-SARS-CoV-2 activity can allow it to help hospitalized patients and add to preparedness for related viruses that might emerge in the future.
VIR-7831 has potential in a hospital setting
Dr. Hal Barron, GSK’s Chief Scientific Officer, said that there is an increase in new infections and hospitalization cases and thus there is a need for several options to combat the pandemic. Barron explained that the company is developing solutions that can help fight the virus from prevention to treatment and thus offer relief to coronavirus related illness. He said that VIR-7831 has a high barrier to resistance and can potentially neutralize the virus and kill infected cells. Therefore, this allows VIR-7831 to be an effective treatment for hospitalized patients where other antibodies have been less effective.
Notably, VIR-7831 is being evaluated in the Phase 2/3 COMET-ICE global trial for early treatment of COVID-19 patients at risk of hospitalization.
