COCP News & Events

Cocrystal Pharma announced that the FDA has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988, the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection.

Cocrystal Pharma announces the first subjects have been dosed in a Phase 1b norovirus challenge study to evaluate CDI-988 as both a preventive and treatment for norovirus infections. This cohort is to assess the infectivity rate of the challenge inoculum, GII.2. CDI-988 is a direct-acting, oral antiviral designed to inhibit a highly conserved region of the viral 3CL protease present in all known norovirus strains, including GII.2, GII.4 and recently re-emerging GII.17 variants. It is the first oral antiviral drug candidate developed for norovirus acute gastroenteritis.

Cocrystal Pharma announces the approval from the Institutional Review Board, IRB, at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. This study aims to evaluate CDI-988 as both a preventive and treatment for norovirus infections. Initial screening of study subjects is currently underway, with enrollment expected to begin in the first quarter of 2026. The IRB approval from Emory University School of Medicine follows Cocrystal's prior regulatory milestones, including U.S. Food and Drug Administration clearance of its investigational New Drug application.

"We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988, our oral broad-spectrum protease inhibitor," said Sam Lee, Ph.D., President and co-CEO of Cocrystal. "This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection. Norovirus is a major cause of acute gastroenteritis and is highly contagious. It spreads rapidly in enclosed environments such as cruise ships, military bases, nursing homes, and hospitals. At present, there is no FDA-approved treatment or prevention for norovirus infection."