GSK, "Antibody Therapy 'Sotrovimab' Effective Against Omicron Variant in Preclinical Studies"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] GSK (GlaxoSmithKline) announced on the 2nd (local time) that its COVID-19 antibody treatment 'Sotrovimab,' co-developed with Vir Biotechnology, showed efficacy against the Omicron COVID-19 variant in preclinical studies.

On the same day, GSK and Vir published preclinical results on the preprint server 'bioRxiv' showing that Sotrovimab maintains activity against key mutations found in the Omicron variant through pseudovirus tests targeting specific individual mutations identified in Omicron.

Sotrovimab is a single-dose COVID-19 antibody treatment developed for adults and pediatric patients at high risk of progressing to severe COVID-19 who do not require supplemental oxygen therapy.

George Scangos, CEO of Vir, explained, "Sotrovimab was deliberately designed with variant viruses in mind," adding, "We targeted highly conserved regions of the spike protein that are less likely to mutate, hoping to address both the existing COVID-19 virus and future variants we anticipate."

Hal Barron, Chief Scientific Officer (CSO) of GSK, stated, "Since the early days of the pandemic, we have been striving to provide continuous treatment options for COVID-19 patients," and added, "These preclinical results support our belief that Sotrovimab can maintain efficacy even as the virus continues to mutate."

In June, GSK and Vir announced Phase 3 clinical trial results showing that Sotrovimab reduced the risk of hospitalization or death by 79% compared to placebo up to 29 days after treatment. Sotrovimab is administered via intravenous infusion over more than 30 minutes.

Meanwhile, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Sotrovimab (product name 'Xevudy') on the same day. Based on Phase 3 clinical data submitted by GSK and Vir, the MHRA cited Sotrovimab's safety and efficacy in reducing the risk of hospitalization and death in COVID-19 patients as reasons for approval. Accordingly, Sotrovimab became the second monoclonal antibody treatment approved in the UK following Roche's 'Ronapreve.'

Sotrovimab currently has Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for treating mild to moderate COVID-19 in high-risk patients and is under rolling review by the European Medicines Agency (EMA) in the European Union (EU).