Pharma Focus Asia

ACTG and Shionogi Announce Progress on Global Phase 3 Trial of Novel COVID-19 Oral Antiviral Agent S‑217622

Thursday, March 17, 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-2d (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).

SCORPIO-HR is a phase 3, multicenter, randomized, double‑blind, 48‑week study that will evaluate the safety and efficacy of S-217622 among participants who have tested positive for SARS-CoV-2 in the outpatient setting, started experiencing symptoms within five days of enrolling, and have one or more risk factors that makes them more likely to progress to severe COVID-19. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for S-217622, enabling SCORPIO-HR to proceed. This trial follows supportive, positive results from phase 2a and phase 2b clinical trials (primarily conducted in Japan and used for submission to the Japanese health authority) that demonstrated proof of concept with significant antiviral activity and rapid cessation of infectious virus shedding.

“While S-217622 is in the same class of treatments as oral medications that are currently available through Emergency Use Authorizations to treat COVID-19, it is administered without a boosting agent and only once daily, which can simplify treatment,” said Annie Luetkemeyer, M.D., University of California, San Francisco and a lead investigator of S-217622. “We need more well-tolerated, highly effective options to treat COVID-19 that reduce the risk of serious complications and the duration of infectiousness. Based on preliminary clinical trial data, we are excited about the potential for S-217622 to be an important addition to our COVID-19 treatment toolkit.”

SCORPIO-HR will be conducted with trial sites in countries in Europe, South America, North America, Africa, and Asia. Approximately 1,700 participants will be randomized in a 2:1 ratio such that two thirds receive S-217622 and one third receive placebo. Participants may take locally provided COVID-19 treatment after enrollment, as long as it is compatible with S-217622.

“As more and more people begin to resume their daily lives, there remains a clear need for effective antiviral treatments for COVID-19 that can offer added protection against severe illness and reduce the burden of COVID-19 on our healthcare systems,” said Isao Teshirogi, Ph.D., President and CEO at Shionogi & Co., Ltd. “As a potent antiviral, specifically designed to inhibit SARS-CoV-2’s ability to spread through the body, S-217622 has demonstrated the largest reductions reported to date in infectious virus titer and rapid cessation of infectious virus shedding. We value the collaboration and support of the NIH and ACTG on this investigational antiviral to bring further treatment options to a broad range of COVID-19 patients, and especially to high-risk populations.”

SCORPIO-HR is led by Kara W. Chew, M.D., M.S., University of California, Los Angeles (UCLA), Dr. Luetkemeyer, and Davey Smith, M.D., University of California, San Diego (protocol co-chairs) and David Alain Wohl, M.D., University of North Carolina (UNC) and Eric S. Daar, M.D., Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs), and is supported by Judith Currier, M.D., M.Sc., UCLA (ACTG Chair) and Joseph J. Eron, M.D., UNC, (ACTG Co-Chair).

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