Vir, GSK Halt Trial Enrollment for COVID-19 Antibody Candidate Following Dull Results
Vir Biotechnology and GlaxoSmithKline (GSK) recently announced that their experimental COVID-19 drug will not be administered to new patients following results of a late-stage study that showed it may not be performing as well as hoped.
The study of VIR-7831, which is a dual-action SARS-CoV-2 monoclonal antibody, was recommended to be closed to enrollment by an independent data monitoring board, stating that "there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit."
The board recommended that the VIR-7831 arm of the trial be closed to new patients while waiting for the data to mature. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program is a clinical trial that started in December 2020 under the National Institute of Health (NIH), which aimed to assess the effects of different drug candidates on adults that are hospitalized with COVID-19.
In April 2020, Vir and GSK announced their collaboration to include the research and development of new therapies for influenza and other respiratory viruses, including coronaviruses.
VIR-7831 is an investigational, dual-action monoclonal antibody that has been shown in preclinical trials to both block viral entry into healthy cells and clear infected cells, which may protect patients from disease progression.
Monoclonal antibodies are synthetically manufactured copies of the human body's natural infection-fighting proteins and are already being used to treat some types of cancers. In the case of COVID-19 infection, the VIR-7831 neutralizes 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.
Vir and GSK will continue their discussions with the NIH to determine the next steps to assess VIR-7831's effectiveness in COVID-19 patients. Aside from the ACTIV Phase III trial, VIR-7831 is also being evaluated in two other clinical trials in the outpatient setting, the COMET-ICE, and the BLAZE-4.
The COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE) is a Phase III trial to evaluate VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death.
The BLAZE-4 is a Phase II trial designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.
As of this morning, Vir’s stocks were down more than 30%.