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Enrollment Completed in Phase 2a Study with Cocrystal Pharma’s Oral Antiviral Candidate CC-42344 for Pandemic and Seasonal Influenza
BOTHELL, Wash., May 01, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces completion of enrollment of 78
About this update from Cocrystal Pharma, Inc.
[{"type":"text","content":"BOTHELL, Wash., May 01, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces completion of enrollment of 78 subjects who were infected with influenza A in a randomized, double-blind, placebo-controlled Phase 2a human challenge clinical study evaluating the safety, tolerability, antiviral and clinical measurements of its novel, broad-spectrum, oral PB2 inhibitor CC-42344. CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A, and was discovered using the Company’s proprietary structure-based drug discovery platform technology. “There is an urgent need for new influenza antivirals targeting highly pathogenic avian pandemic and seasonal influenza strains. It’s gratifying to report the timely completion of enrollment in this important study, keeping us on track to announce topline results later this year. This human challenge study was conducted in the United Kingdom and was designed to evaluate a favorable safety profile, virological effects, and an improvement in clinical symptom for CC-42344 as a potential oral treatment for avian pandemic and seasonal influenza A,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are pleased to advance our robust pipeline with achievement of this important clinical development milestone as we continue to build our leadership in influenza therapeutics.” In March 2024 Cocrystal announced receipt of positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA providing guidance and clarification on critical steps including designing a proposed Phase 2b study protocol for CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. Cocrystal also plans to begin a Phase 1 study in Australia with an inhaled formulation of CC-42344 as a potential influenza A treatment and post-exposure prophylaxis. Recent preclinical data showed that inhaled CC-42344 exhibited highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia and a favorable safety profile. CC-42344 Influenza A PB2 Inhibitor In December 2023, Cocrystal announced the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new ...