Cocrystal Pharma Receives Study May Proceed Letter From FDA To Conduct Phase 1b Challenge Study Evaluating CDI-988 For Prevention And Treatment Of Norovirus Infections; Phase 1b Challenge Study Is Planned To Begin Before Year-End 2025

Author: Benzinga Newsdesk | September 08, 2025 07:01am

• 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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