Shionogi has been awarded $375m by the US Department of Health and Human Services (HHS) to develop a long-acting therapeutic aimed at protecting vulnerable populations from Covid-19.
The funding – provided through the Rapid Response Partnership Vehicle (RRPV) under the Biomedical Advanced Research and Development Authority (BARDA) – is part of the $5bn Project NextGen initiative. This programme is designed to advance next-generation vaccines, therapeutics, and other tools to combat Covid-19.
The therapeutic, dubbed S-892216, leverages protease inhibitor technology to block the main protease (Mpro) of the SARS-CoV-2 virus, preventing it from replicating within human cells. This type of technology has been successfully used in treatments for diseases such as human immunodeficiency virus (HIV) and hepatitis C. Unlike traditional antiviral treatments given after infection, S-892216 is being developed as a pre-exposure prophylaxis (PrEP) drug, meaning it is designed to protect people before they are exposed to the virus.
Such preventative measures are particularly critical for immunocompromised individuals, who may not respond adequately to vaccines or could be at higher risk of severe outcomes from Covid-19. This group includes people undergoing treatment for cancer, organ transplant recipients, and those taking immunosuppressive medications. The development of S-892216 reflects an ongoing need for diverse solutions to address Covid-19, particularly as the virus continues to evolve.
Shionogi will advance the clinical development of a long-acting injectable formulation of S-892216, and the company plans to file an investigational new drug application with the US Food and Drug Administration (FDA) this year, and initiate Phase I clinical trials. If successful, the therapeutic could fill a significant gap in the Covid-19 treatment landscape by providing a long-lasting preventative option for high-risk populations.
Shionogi has prior experience in Covid-19 drug development. In 2024, the company’s antiviral drug Xocova (ensitrelvir) received full approval in Japan, but the Phase III SCORPIO-HR trial studying the drug failed to meet its primary endpoint. However, subsequent data suggested that Xocova reduced symptomatic infections in household settings when compared to placebo. Xocova also targets a protease enzyme essential for SARS-CoV-2 replication.
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By GlobalData