Cocrystal Pharma Concludes Enrolment in Phase 2a Study of CC-42344

Cocrystal Pharma, Inc. reports that the randomized, double-blind, placebo-controlled phase 2a human challenge clinical study assessing the safety, tolerability, antiviral, and clinical measurements of its novel, oral PB2 inhibitor CC-42344, which is intended to treat influenza A, has enrolled 78 subjects. Using the Company's patented structure-based drug discovery platform technology, CC-42344 is a novel class of antiviral therapy that is intended to efficiently block a crucial stage in the viral replication and transcription of pandemic and seasonal influenza A, as well as other viruses.

“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.”

CC-42344 is a prospective oral treatment for pandemic and seasonal influenza A. Cocrystal announced in March 2024 that it had received positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA. This feedback included guidance and clarification on critical steps, such as designing a proposed phase 2b study protocol.

Cocrystal also intends to conduct a phase 1 research in Australia using an inhalation version of CC-42344 as a possible influenza A therapy and post-exposure prevention. Recent preclinical findings demonstrated that inhaled CC-42344 had a high rate of lung delivery, superior lung exposure, effectiveness in influenza-infected human lung epithelia, and an acceptable safety profile.