Shionogi Advances Development of Long-Acting COVID-19 Antiviral with BARDA Support
Shionogi & Co., Ltd., a leading pharmaceutical company based in Osaka, Japan, has announced a significant step forward in the fight against COVID-19. The company's New Jersey-based subsidiary, Shionogi Inc., has been awarded a $375 million project agreement through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA). This funding is aimed at advancing the development of S-892216, a long-acting injectable antiviral for COVID-19 pre-exposure prophylaxis.
Addressing Unmet Needs in COVID-19 Prevention
The project focuses on developing S-892216, a second-generation 3CL protease inhibitor, as a long-acting injectable solution. This initiative seeks to fill a critical gap in the current arsenal of COVID-19 therapeutics by providing a pre-exposure prophylaxis option that could protect at-risk populations from severe outcomes of the disease. Shionogi plans to file an investigational new drug application in the U.S. and commence phase 1 studies within the year.
John Keller, Ph.D., Senior Executive Officer and Senior Vice President of the R&D Supervisory Unit at Shionogi, emphasized the importance of this development: "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."
S-892216: A Dual-Formulation Approach
S-892216 is being developed in two forms: a long-acting injectable for pre-exposure prophylaxis and an oral formulation for the treatment of SARS-CoV-2 infection. Pre-clinical trials have demonstrated the compound's strong antiviral effect, supporting its potential as a key tool in managing the COVID-19 pandemic.
Shionogi's commitment to combating infectious diseases extends beyond S-892216. The company is also advancing the development of ensitrelvir (Xocova®), another COVID-19 oral antiviral, which has received Fast Track designation by the U.S. Food and Drug Administration and approval in Singapore.
A Global Commitment to Health Security
Shionogi's efforts are part of a broader commitment to protect people worldwide from the threat of infectious diseases. The company is working towards equitable access to its treatments, including collaborations with the Medicines Patent Pool to ensure availability in low- and middle-income countries. By strengthening its manufacturing and global supply chain, Shionogi aims to contribute significantly to re-establishing the safety and security of society amidst the ongoing pandemic.
This announcement underscores Shionogi's dedication to addressing global health challenges through innovative research and development, supported by strategic partnerships like the one with BARDA. As the world continues to navigate the complexities of the COVID-19 pandemic, developments such as S-892216 represent hope for more effective prevention and treatment options.
