GlaxoSmithKline and Vir Biotechnology announced that final results from a phase 3 study of their monoclonal antibody confirmed it significantly reduced hospitalization and death among high-risk COVID-19 patients when given early in the disease.
The 1,057-patient COMET-ICE trial demonstrated that the investigational treatment, sotrovimab, resulted in a 79% reduction in risk of hospitalization for more than 24 hours or death due to any cause, by day 29, compared to placebo — meeting the primary endpoint of the trial. Six patients in the sotrovimab arm versus 30 patients in the placebo arm were hospitalized for >24 hours for acute management of any illness or death from any cause.
The treatment is the result of Vir-GSK collaboration announced in April 2020 which uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies.
Sotrovimab received an emergency use authorization from the U.S. FDA in May. GSK and Vir plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.The EMA has started a rolling review of sotrovimab data that will continue until enough evidence is available to support the filing of a formal marketing authorization application.
The mAb is administered by intravenous drip but GSK is currently testing it as an intramuscular shot, which the hopes of making administration more convenient.