Vir and GSK halt trial of its Covid-19 antibody raising concern over potential benefit
The two giants had collaborated to include the research and development of new therapies for influenza and other respiratory viruses including Covid-19
Updating on the drug VIR-7831 (GSK 4182136), jointly developed by Vir Biotechnology and GlaxoSmithKline (GSK), the National Institute of Health (NIH) reported that they are halting the enrolment for the Covid-19 antibody trial. NIH's Accelerating Covid-19 Therapeutic Interventions and Vaccine (ACTIV) Program Phase 3 clinical trials provided the update.
Meeting the initial pre-specified criteria VIR-7831 continues to the next phase of the ACTIV-3 trial, but there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. Such concerns regarding the magnitude of potential benefit led the Independent Data and Safety Monitoring Board (DSMB) recommending that the VIR-7831 arm of the trial be closed. This recommendation is based on the data review conducted on 300 hospitalized Covid-19 patients who are a part of ACTIV-3.
The company will continue to discuss with NIH regarding the potential assessment in the hospitalized population to gain further information concerning more data collection. As per the recommendation, the trial of the drug is closed to new patients until more data is collected. The ACTIV program is a clinical trial program under the aegis of NIH, assessing the compatibility of different drug candidates on adults hospitalized with Covid-19.
In April 2020, the two giants Vir and GSK collaborated to include the research and development of new therapies for influenza and other respiratory viruses including Covid-19. VIR-7831 is a dual-action monoclonal antibody. During the pre-clinical trials, the drug showed efficiency in blocking the viral entry into the healthy cells and clear infected cells thereby, protecting the patients from the progression of the disease. The antibody has also shown the ability to neutralize the SARS-CoV-2 live virus by binding to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.
Speaking on the said recommendation, George Scangos, CEO 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."
While Senior Vice President (Development), GSK, Christopher Corsico 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 into how VIR-7831 can contribute to the fight against this pandemic."