Core Insights - Cocrystal Pharma, Inc. announced significant progress in the development of CDI-988, a pan-viral protease inhibitor, which may serve as the first oral antiviral for norovirus prevention and treatment [1][2] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing innovative antiviral treatments for diseases such as influenza, viral gastroenteritis, COVID, and hepatitis [9] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs [9] Product Development - CDI-988 was designed using Cocrystal's proprietary structure-based drug discovery platform, demonstrating broad-spectrum antiviral activity against multiple norovirus genogroups, including GII.4 and GII.17 [3][6] - The Phase 1 study of CDI-988 has been completed, showing a favorable safety profile with no serious adverse events reported [4] - The U.S. FDA has granted clearance for a Phase 1b human challenge study to further evaluate CDI-988 as a potential prophylaxis and treatment for norovirus, expected to begin before the end of 2025 [2][4] Scientific Presentation - Dr. Sam Lee, President and co-CEO of Cocrystal, presented the Phase 1 data at the 9th International Calicivirus Conference, highlighting CDI-988's mechanism of action and its potential as a GI-targeted antiviral [1][2] - The drug exhibits high exposure in the small intestine, which is critical for targeting norovirus infections [2] Industry Context - Norovirus is the leading cause of viral gastroenteritis globally, responsible for significant healthcare costs estimated at $60 billion due to direct healthcare expenses and lost productivity [7] - The Calicivirus Conference serves as a platform for global experts to discuss advancements in calicivirus research, fostering collaboration and innovation in the field [5]

Virology - Respiratory Syncytial Virus (RSV) - Zelicapavir (EDP-938) is the only N-inhibitor in clinical development for RSV, with Phase 2 pediatric study complete and Phase 2 high-risk adult study ongoing[17, 6] - In a Phase 2 pediatric study, zelicapavir showed a viral load decline of 0.88 log at Day 3 and 1.18 log at Day 5 in the prespecified mITT-3 population[25] - EDP-323, an RSV L-protein inhibitor, demonstrated 85-87% reduction in viral load AUC in a human challenge model[42] - A Phase 2 high-risk adult study is designed to show a clinically meaningful reduction in symptom duration of at least ~1 day with Zelicapavir[37] Immunology - The company is developing a KIT inhibitor for mast cell driven diseases like Chronic Spontaneous Urticaria (CSU) and a STAT6 inhibitor for type 2 immune diseases like atopic dermatitis[6] - EPS-1421, a KIT inhibitor development candidate, inhibits KIT with nanomolar potency and demonstrates sub-nanomolar activity in vivo[63] - Prototype STAT6 inhibitors inhibit STAT6 with nanomolar potency and are highly selective for STAT6 versus other STATs[79] - Prototype STAT6 oral inhibitor results in complete inhibition of pSTAT6 in a mouse model[89] Financial Status - The company had $193.4 million in cash as of March 31, 2025[6] Business Development - The company plans to pursue partnerships for zelicapavir and/or EDP-323[102]