SGIOF - Shionogi gets FDA nod to begin phase 3 study of oral COVID drug S-217622

Shionogi (OTCPK:SGIOF) (OTCPK:SGIOY) said the U.S. FDA cleared its investigational new drug (IND) for oral COVID-19 drug S-217622, allowing a global phase 3 trial to proceed as part of the ACTIV-2 program. The phase 3 trial, ACTIV-2d (also known as SCORPIO-HR), will evaluate S-217622 as a once-daily oral therapy for high-risk, non-hospitalized adults with COVID-19 within five days of symptom onset. The company said the trial follows results from phase 2a and phase 2b trials, primarily conducted in Japan and used for submission to the Japanese health authority. The trial sites will be in Europe, South America, North America, Africa, and Asia with ~1.7K participants. The study 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).

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Shionogi gets FDA nod to begin phase 3 study of oral COVID drug S-217622