GSK and Vir Biotechnology Pause Enrollment in Phase 3 ACTIV-3 Trial of VIR-7831 for Hospitalized COVID-19 Patients
GSK
Pharmaceutical R&D Manufacturer
Vir Biotechnology
Developer of Immunological Drugs
National Institutes of Health
The National Institutes of Health (NIH), which began in 1887 as a one-room hygiene laboratory, has since become one of the world’s most important medical research centers. As an agency within the U.S. Department of Health and Human Services, the NIH serves as the federal government’s principal center for health research.The NIH is the steward of medical and behavioral research for the nation. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability.
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On March 3, GlaxoSmithKline (GSK) and its partner Vir Biotechnology provided an update on the VIR-7831 (GSK4182136) arm of the Phase 3 clinical trial under the National Institutes of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial evaluated the efficacy and safety of VIR-7831 in adult patients hospitalized with COVID-19.
According to the announcement, both parties have been informed that although VIR-7831 met the initially prespecified criteria for proceeding to the next phase of the ACTIV-3 trial and no safety signals were reported, sensitivity analyses of the existing data raised concerns regarding the magnitude of potential benefit.
The Independent Data and Safety Monitoring Board (DSMB) recommended halting enrollment in the VIR-7831 arm of the trial until data maturity is reached. As stakeholders gain a more comprehensive understanding of the continually emerging data, GSK and Vir Biotechnology will continue discussions with the National Institutes of Health (NIH) to determine appropriate approaches for further evaluating the potential of VIR-7831 in hospitalized patients.
The DSMB’s recommendations were based on a review of routine, pre-planned safety and efficacy data from the first 300 COVID-19 patients enrolled in the ACTIV-3 trial.
VIR-7831 is an investigational, dual-action monoclonal antibody. Preclinical studies have demonstrated that it can both block viral entry into healthy cells and clear infected cells, thereby protecting patients from disease progression. The antibody has also shown the ability to neutralize live SARS-CoV-2 by binding to a highly conserved spike protein epitope, which may make the development of resistance more difficult. To date, variants of concern, including those identified in the United Kingdom, South Africa, and Brazil, do not exhibit mutations overlapping with the VIR-7831 target epitope. Therefore, Vir Biotechnology and GSK believe that the antibody should retain sufficient activity against these variants.
In addition to the ACTIV-3 trial, the following clinical trials are also evaluating VIR-7831 in the outpatient setting:
——COMET-ICE (COVID-19 Monoclonal Antibody Efficacy Trial–Early Care Objective): A Phase 3 trial evaluating the efficacy of early treatment with VIR-7831 in adults with COVID-19 at high risk for hospitalization or death.
—BLAZE-4 (sponsored by Eli Lilly and Company): A Phase 2 trial designed to evaluate the safety and efficacy of Eli Lilly’s monoclonal antibody bamlanivimab (LY-CoV555) as monotherapy, bamlanivimab in combination with other neutralizing antibodies (including VIR-7831), and placebo in low-risk adults with mild to moderate COVID-19.
Furthermore, VIR-7831 and VIR-7832 will be evaluated in adults with mild-to-moderate COVID-19 in the National Health Service (NHS)-supported AGILE Phase 1b/2a trial. VIR-7832 is the second monoclonal antibody under investigation by Vir Biotechnology and GSK as a potential treatment for COVID-19.
References:
1.GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3
2.Vir Biotechnology and GSK provide update on NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalised adults with COVID-19
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.