On Jan. 16, 2025, Shionogi Inc. 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.

The 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.

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).

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.