- FDA has cleared the IND for S-217622, a once-daily investigational oral antiviral therapy, enabling the global phase 3 trial to proceed as part of the ACTIV-2 program for COVID-19
- This NIH-supported study will recruit participants with COVID-19 worldwide who are at risk for progression to severe illness
Los Angeles, Calif. and Osaka, Japan, March 16, 2022 – The AIDS Clinical Trials Group (ACTG), the largest global HIV research network that expanded its focus to include evaluating outpatient treatments for COVID-19, and Shionogi & Co., Ltd., a global pharmaceutical company headquartered in Osaka, Japan with a long-standing commitment to the research and development of innovative, high-quality infectious disease medicines, today announced progress toward the initiation of ACTIV-2 (also known as SCORPIO-HR), a global, phase 3, multicenter trial to evaluate the safety and efficacy of the COVID-19 antiviral agent S-217622. SCORPIO-HR will evaluate the investigational 3CL protease inhibitor S-217622 as a once-daily oral treatment for high-risk, non-hospitalized adults with COVID-19 within five days of symptom onset. The trial is being conducted by ACTG, sponsored by Shionogi, and funded by the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH).