SRNE - Sorrento trial for oral COVID-19 therapy granted regulatory nod in China
- U.S. biopharma Sorrento Therapeutics, Inc. ( NASDAQ: SRNE ) announced Friday that the company received regulatory clearance from the China National Medical Products Administration (NMPA) to conduct an early-stage clinical trial for its oral COVID-19 therapy STI-1558 in China.
- The double-blind and placebo-controlled study will be designed to assess the safety and efficacy of the protease inhibitor in 56 subjects with COVID-19 in multiple ascending doses.
- The trial with three dose cohorts will test 300 mg BID (n=8), 600 mg BID (n=24) and 800 mg BID (n=24) of STI-1558 against placebo.
- The trial conducted by Sorrento ( SRNE ) company ACEA Therapeutics, Inc. and the Third Shenzhen Hospital in Shenzhen, China, is expected to support the plans to seek a potential Emergency Use Authorization (EUA) for the candidate in the country.
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Sorrento trial for oral COVID-19 therapy granted regulatory nod in China