Cocrystal Pharma Inc. (NASDAQ: COCP) said it has finished dosing in a Phase 1b norovirus challenge study evaluating its oral antiviral candidate CDI-988. The study, conducted at Emory University School of Medicine, is a randomized, double-blind, placebo-controlled trial involving healthy adults aged 18 to 49 who were challenged with the Norovirus GII.2 strain.
The primary endpoint of the study is the reduction of clinical symptoms compared with placebo, while secondary endpoints include measures of viral shedding, disease severity, safety, and pharmacokinetic profiles. To date, no serious adverse events have been reported among participants.
Prior to this trial, Cocrystal completed a Phase 1 study in Australia that demonstrated safety and tolerability across all dose levels, up to the highest tested dose of 1200 mg. The same 1200 mg dose is being used in the current Phase 1b challenge study.
According to the company, norovirus causes an estimated 21 million infections annually in the United States, leading to approximately 109,000 hospitalizations and 465,000 emergency department visits. Globally, about 685 million cases occur each year. Cocrystal Pharma describes itself as a clinical-stage biotechnology firm focused on developing antiviral therapeutics for noroviruses, influenza, coronaviruses, and hepatitis C virus.
