Clinical TrialApr 30, 2026, 04:05 PM
COCP CDI-988 Phase 1b Study Underway; FDA Fast Track Granted
AI Summary
Cocrystal Pharma announced the clinical advancement of its oral protease inhibitor CDI-988 for norovirus, featured at the 39th International Conference on Antiviral Research. The drug is currently in an ongoing Phase 1b human challenge study, with the first cohort fully enrolled to establish inoculum infectivity. CDI-988 has also received FDA Fast Track designation for norovirus treatment and prophylaxis, underscoring the serious nature of the disease and the lack of approved therapies. Preclinical and Phase 1 data showed favorable pharmacokinetics and safety for the compound, which targets a highly conserved region of the 3CL protease.
Key Highlights
- CDI-988 Phase 1b human challenge study for norovirus is ongoing.
- First cohort of the Phase 1b study is fully enrolled (up to 40 healthy adults).
- CDI-988 received FDA Fast Track designation for norovirus treatment and prophylaxis.
- Phase 1 study showed CDI-988 was safe and well tolerated up to 1,200 mg.
- Norovirus causes an estimated 685 million cases and 200,000 deaths globally annually.
- Norovirus has an approximate $60 billion worldwide annual economic impact.
Price Impact
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