Cocrystal Pharma Receives IRB Approval from Emory University School of Medicine for Phase 1b Human Challenge Study with CDI-988 for Prevention and Treatment of Norovirus

Core Insights - Cocrystal Pharma has received approval from the Institutional Review Board at Emory University to initiate a Phase 1b human challenge study for CDI-988, aimed at preventing and treating norovirus infections [1][4] - CDI-988 is the first oral antiviral drug candidate specifically designed to target norovirus, including strains GII.4 and GII.17 [2] - The Phase 1b study will involve up to 40 healthy subjects and will assess the efficacy, safety, and pharmacokinetics of CDI-988 [3] Company Developments - The study's primary endpoint is to evaluate the reduction in clinical symptoms, while secondary endpoints include viral shedding and disease severity [3] - Cocrystal's President highlighted the significance of this study in addressing the global burden of norovirus, which causes approximately 700 million cases annually [5] - CDI-988 has shown favorable safety and tolerability data in previous Phase 1 trials, with the highest dose being 1200 mg [6] Industry Context - Norovirus is a highly contagious virus responsible for around 200,000 deaths globally each year, with significant economic impacts estimated at $60 billion [7] - In the U.S., norovirus leads to about 21 million cases of acute gastroenteritis annually, resulting in substantial healthcare costs [7] - There are currently no approved treatments or vaccines for norovirus, highlighting the potential market opportunity for CDI-988 [9]