Shionogi & Co., Ltd.

S-892216 is being developed as a pre-exposure prophylaxis (PrEP) drug for Covid-19. Credit: seksan Mongkhonkhamsao via Getty Images. 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.

OSAKA, Japan--( BUSINESS WIRE )--Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced Shionogi Inc., a New Jersey-based subsidiary of Shionogi, has been awarded a $375 million project agreement through the Rapid Response Partnership Vehicle (RRPV), to advance the development of S-892216, a 3CL protease inhibitor, as a long-acting injectable for COVID-19 pre-exposure prophylaxis. RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This project award will address a gap for pre-exposure prophylaxis therapeutics that have the potential to provide protection against severe outcomes of COVID-19. Shionogi plans to file an investigational new drug application in the U.S. and begin phase 1 studies this year. “COVID-19 continues to be a serious global health risk even with available vaccines and treatments. We share BARDA’s recognition of this unmet need and appreciate its selection of S-892216 for this important program,” said John Keller, Ph.D., Senior Executive Officer, Senior Vice President, R&D Supervisory Unit at Shionogi. “With our deep expertise in antiviral drug development, continually expanding knowledge of COVID-19 and support from BARDA, we will advance the pre-exposure prophylaxis program for S-892216 at pace with public health needs.” This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005. About S-892216 S-892216, an investigational second generation 3CL protease inhibitor, is being developed both as a long-acting injectable and as an oral drug, intended for prophylaxis and treatment of SARS-CoV-2 infection respectively. In pre-clinical trials, S-892216 demonstrated a strong antiviral effect. S-892216 was discovered by Shionogi and its research and development is supported by the Japan Agency for Medical Research and Development (AMED) under Grant Numbers JP21fk0108584 and 22fk0108522h0001. The S-892216 oral formulation is being studied in a Phase 1 clinical trial in Japan to evaluate the pharmacokinetics, safety, and tolerability in healthy adults. A Phase 1 clinical trial with the long-acting injectable formulation is expected to begin in 2025. In addition to S-892216, Shionogi continues its extensive global development program for the novel COVID-19 oral antiviral ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622), known as Xocova® 125 mg tablet in Japan. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 and it was approved in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore. About Shionogi in Infectious Disease Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” with research and development of therapeutics, whilst also working towards total care through awareness building, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating infections directly. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent a global threat, Shionogi will seek to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic. Shionogi is committed to equitable access worldwide, including by working with the Medicines Patent Pool to provide access to low- and middle-income countries (LMICs) , and by strengthening its manufacturing and global supply chain. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

After seeing its Covid-19 drug fail in a Phase 3 trial last year, Shionogi on Thursday won a $375 million award from HHS to develop a preventive drug for the disease. The drug is aimed to protect people who are immunocompromised and will use protease inhibitor technology to prevent the virus from replicating, the HHS’ Administration for Strategic Preparedness and Response said in a statement. The award, part of the $5 billion Project NextGen , aims to address a gap in therapeutics that prevent against severe Covid outcomes, Shionogi said in a press release . The company said it plans to file an investigational new drug application for its therapeutic in the US this year and start Phase 1 trials. Last May, Shionogi’s Covid antiviral ensitrelvir missed its primary endpoint in a Phase 3 study, two months after scoring full approval in Japan. But in October, the Japanese company touted that ensitrelvir showed a statistically significant decrease in the proportion of patients with a symptomatic infection through 10 days after being exposed to household members with Covid-19 when compared to placebo.