Cocrystal Pharma Enrolls Phase 1b CDI-988 Norovirus Cohort, Earns Fast Track Status
Cocrystal Pharma’s Phase 1b study of CDI-988 has fully enrolled its cohort testing GII.2 norovirus infectivity after Phase 1 showed safety and tolerability with no serious adverse events. CDI-988 targets the conserved 3CL protease, has Fast Track status and could address a $60 billion norovirus market with no approved therapies.
1. Conference Presentation at ICAR 2026
Cocrystal Pharma President and co-CEO Sam Lee delivered an oral presentation at the International Conference on Antiviral Research in Prague, highlighting CDI-988’s mechanism of action as the first oral direct-acting norovirus protease inhibitor and summarizing favorable Phase 1 outcomes.
2. Phase 1b Human Challenge Study Enrollment
The ongoing randomized, double-blind Phase 1b study at Emory University and UNC has fully enrolled its stage 1 cohort to validate infectivity of the GII.2 (Snow Mountain Virus) inoculum, paving the way for prevention and treatment cohorts administering 1,200 mg twice daily.
3. FDA Fast Track Designation and Market Opportunity
CDI-988 has received FDA Fast Track designation for both prevention and treatment of norovirus infection, underscoring the lack of approved therapies. The drug could address an estimated $60 billion annual global norovirus burden across all age groups and genotypes.