JAPAN – Shionogi has received US $375 million in funding from the US Department of Health and Human Services (HHS) to develop a long-acting therapeutic designed to protect vulnerable populations from Covid-19.
The funding, awarded through the Rapid Response Partnership Vehicle (RRPV) under the Biomedical Advanced Research and Development Authority (BARDA), is part of the US $5 billion Project NextGen initiative.
This program aims to accelerate the development of next-generation vaccines, therapeutics, and tools to combat the ongoing challenges posed by Covid-19.
The therapeutic, known as S-892216, utilizes protease inhibitor technology to block the main protease (Mpro) of the SARS-CoV-2 virus, preventing it from replicating within human cells.
This approach, previously used successfully in treatments for HIV and hepatitis C, is now being adapted for Covid-19.
Unlike traditional antiviral treatments administered after infection, S-892216 is being developed as a pre-exposure prophylaxis (PrEP) drug, designed to protect individuals before exposure to the virus.
Preventative measures like S-892216 are especially vital for immunocompromised individuals who may not respond effectively to vaccines or are at heightened risk of severe outcomes from Covid-19.
These groups include cancer patients, organ transplant recipients, and those taking immunosuppressive medications.
Shionogi’s development of this therapeutic underscores the ongoing need for diverse strategies to address Covid-19 as the virus continues to evolve.
Shionogi plans to advance the clinical development of a long-acting injectable formulation of S-892216, with an investigational new drug application set to be submitted to the US Food and Drug Administration (FDA) this year.
Phase I clinical trials will follow. If successful, the therapeutic could address a significant gap in the Covid-19 treatment landscape by offering a durable preventative solution for high-risk populations.
The company brings previous experience in Covid-19 drug development to this project. In 2024, Shionogi’s antiviral drug Xocova (ensitrelvir) received full approval in Japan.
Although the Phase III SCORPIO-HR trial failed to meet its primary endpoint, subsequent data suggested that Xocova reduced symptomatic infections in household settings compared to placebo.
Similar to S-892216, Xocova targets the protease enzyme critical for SARS-CoV-2 replication.