Cocrystal Pharma reports Phase 1 safety, tolerability results of CDI-988

Cocrystal Pharma (COCP) announces safety and tolerability results at dosing up to 800 mg per day for 10 consecutive days from the multiple-ascending dose portion of the ongoing Phase 1 study with its oral protease inhibitor CDI-988, the first pan-viral drug candidate in development as an orally administered treatment of norovirus and coronavirus infections. The Company also announces that an additional cohort with a higher dose of 1,200 mg and a shorter treatment duration of five consecutive days will be conducted to further assess CDI-988’s safety, tolerability and pharmacokinetics. “Norovirus outbreaks are surging across the U.S. as well as on cruise ships with nearly 900 passengers sickened from gastrointestinal disease in December alone,” said Sam Lee, President and co-CEO. “There are currently no approved antivirals or vaccines for norovirus and the ability to curtail outbreaks is limited, making norovirus infection a significant unmet need. We are pleased to report positive Phase 1 results with these data demonstrating that CDI-988 had a favorable safety profile and was well-tolerated, supporting further clinical advancement of this potentially first effective norovirus antiviral. CDI-988 is our first pan-viral protease inhibitor with the potential to be used for prophylaxis and treatment for norovirus and coronavirus infections. We look forward to making a significant impact on norovirus outbreaks with this development candidate,” he added. “We expect to begin enrollment in the Phase 1 study higher-dose cohort in the current quarter and to initiate a human challenge study in norovirus-infected subjects later in 2025.”