As a result of phase three COMET-ICE trial data, GlaxoSmithKline plc and Vir Biotechnology, Inc. announced this week that they will push forward with sotrovimab, an investigational monoclonal antibody treatment for SARS-CoV-2.
Primary efficacy analysis of 1,057 patients who participated in the trial put the treatment’s efficacy at around 79 percent for keeping people with COVID-19 alive and out of the hospital. This was based on data as of 29 days from the application of the treatment, meaning it provided positive ends to a majority of patients about a month after the fact.
The U.S. National Institutes of Health (NIH) appears to have agreed, as it recently updated its COVID-19 treatment guidelines to recommend the drug for non-hospitalized patients with mild-to-moderate COVID-19 cases.
“We are pleased that the profound interim efficacy from the COMET-ICE trial has now been validated by the full study population,” Dr. George Scangos, CEO of Vir, said. “These results, combined with the growing number of pending global authorizations, as well as the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel, support our confidence in the potential role of sotrovimab in the fight against this pandemic.”
While further research is needed to determine the effects of intramuscular administration of sotrovimab as an early treatment among high-risk, mild-to-moderate COVID-19 cases, the NIH also noted that sotrovimab appears effective against SARS-CoV-2 variants as well.
“Effective medicines to treat those who become infected with SARS-CoV-2 remain a critical part of the solution to this pandemic,” Christopher Corsico, senior vice president of Development at GSK, said. “We are working diligently to increase access to sotrovimab in the U.S. and across the globe, including evaluating the potential to simplify administration with an intramuscular formulation.”
According to preclinical data, sotrovimab may have the ability to block viral entry of SARS-CoV-2 into healthy cells and clear infected cells. While it does have side effects, the results of the phase three trial limited these to mild or moderate incidents, with rash and diarrhea being the most common.
Sotrovimab is currently operating under an Emergency Use Authorization from the U.S. Food and Drug Administration. It has received a positive scientific opinion from the European Medicines Agency’s Committee for Human Medicinal Products. Later this year, GSK and Vir intend to submit a Biologics License Application for the treatment to the FDA.
Both companies have indicated that they should be able to manufacture approximately 2 million doses in this first year following emergency use authorization.