HHS grants US$375 M to Shionogi for development of Long-Acting Covid-19 PrEP

JAPAN—The U.S. Department of Health and Human Services (HHS) has granted US$375 million  to Japan-based pharmaceutical company Shionogi to develop a long-acting therapeutic aimed at protecting vulnerable populations from Covid-19.

The funding, provided through Shionogi’s subsidiary in New Jersey, comes as part of the U.S. government’s US$5 billion Project NextGen initiative.

This program is focused on advancing next-generation vaccines, therapeutics, and tools to fight Covid-19.

The therapeutic, named S-892216, uses a protease inhibitor technology to block the main protease (Mpro) of the SARS-CoV-2 virus.

 This prevents the virus from replicating in human cells, a technology already proven effective in treatments for diseases like HIV and hepatitis C.

However, unlike traditional antiviral treatments that are given after an infection, S-892216 is being developed as a pre-exposure prophylaxis (PrEP).

 This means it is designed to protect people before they are exposed to the virus, making it an important option for individuals who are at higher risk of severe Covid-19 outcomes.

Immunocompromised people—such as cancer patients, organ transplant recipients, and those on immunosuppressive medications—are especially vulnerable.

For these individuals, vaccines may not offer adequate protection, and they face a higher risk of severe illness from Covid-19.

As such, S-892216 could provide a vital preventative measure for this at-risk group.

Shionogi’s move into the development of this long-acting injectable is seen as an important step in addressing the ongoing need for diverse Covid-19 treatments, especially as the virus continues to evolve.

The company plans to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) later this year and initiate Phase I clinical trials.

Shionogi’s previous experience in the field of Covid-19 drug development includes its antiviral drug, Xocova (ensitrelvir), which was approved in Japan in 2024.

While a Phase III trial for Xocova did not meet its primary endpoint, later data indicated that it reduced symptomatic Covid-19 infections in household settings when compared to a placebo.

Like S-892216, Xocova also targets a protease enzyme that is crucial for the virus’s replication.

Commenting on the award, Dr. John Keller, Senior Executive Officer at Shionogi, emphasized that despite the availability of vaccines and treatments, Covid-19 remains a serious global health risk.

He expressed gratitude to BARDA for selecting S-892216 for the program and reiterated Shionogi’s commitment to advancing this pre-exposure prophylaxis to meet the evolving public health needs.

With their extensive expertise in antiviral drug development and support from BARDA, Shionogi is positioned to make significant strides in combating the pandemic. 

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