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CocCrystal Pharma收到FDA的研究可能会继续进行1b期挑战研究,评估CDI-988预防和治疗诺如病毒感染的作用; 1b期挑战研究计划在2025年年底前开始

2025-09-08 20:01

  • There are currently no approved vaccines or treatments for norovirus infection
  • Cocrystal's CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
  • Phase 1b study is expected to start by year-end 2025
     

BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) ("Cocrystal" or the "Company") announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal's oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus – the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025.

CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections.

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