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.