British drugmaker GlaxoSmithKline said early-stage lab data shows its COVID-19 monoclonal antibody treatment, jointly developed with U.S. partner Vir Biotechnology, is effective against all mutations of the new Omicron strain.
Glaxo said in a Dec. 7 statement that new preclinical findings generated from in vitro testing of the drug, called sotrovimab, show that the treatment is effective against all 37 identified mutations to date in Omicron’s spike protein.
“These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date” by the World Health Organization (WHO), said Dr. Hal Barron, Chief Scientific Officer and President of Research and Development, at GSK.
The data, which has not yet been peer reviewed, builds on earlier preclinical findings released last week, which showed sotrovimab was effective against key Omicron mutations.
“Sotrovimab is the first monoclonal antibody to report preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the still prevalent and highly contagious Delta variant,” George Scangos, CEO of Vir Biotechnology, said in a statement.
SARS-CoV-2 is the scientific name for the CCP (Chinese Communist Party) virus, the pathogen that causes the disease COVID-19.
While much remains unknown about Omicron, which has been detected in dozens of countries including the United States, it appears to spread more quickly than other variants, though early signs from a study in South Africa suggest it may cause milder illness.
The FDA authorized the antibody treatment for use in people who have mild to moderate COVID-19 and who are at high risk for progression to severe disease.
The known risk of sotrovimab is hypersensitivity reactions, including anaphylaxis and infusion-related reactions, which can range from minor adverse events like dizziness or a skin rash, to potentially life-threatening reactions like difficulty breathing and reduced oxygen saturation, according to an FDA fact sheet (pdf).
“Sotrovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary,” the FDA wrote in its letter of authorization (pdf).
The Glaxo study was run based on a so-called pseudovirus that has been engineered to feature major coronavirus mutations across all suspicious variants that have emerged so far.