GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.
Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.
Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.
The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.
Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be published in a peer-reviewed journal in the first quarter of 2022.
The two companies also plan on investigating the use of sotrovimab to prevent symptomatic COVID-19 infection.
A study at the University of Oxford is also testing the use of the drug candidate in hospitalized COVID-19 patients.
In December, GSK and Vir announced that sotrovimab appears to continue offering strong protection against the omicron variant.
To date, sotrovimab has been the subject of more than one dozen trials.
Filed Under: clinical trials, Drug Discovery, Infectious Disease