Enrollment Completed in Phase 1 Influenza A Study with Cocrystal Pharma’s Oral Antiviral ...

BOTHELL, Wash., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the completion of enrollment in a Phase 1 healthy volunteer study to assess the safety, tolerability and pharmacokinetics (PK) of its orally administered, novel, broad-spectrum antiviral candidate CC-42344 for the treatment of pandemic and seasonal influenza A. CC-42344 represents a new class of antiviral treatment designed to block an essential step in the viral replication and transcription of pandemic and seasonal influenza A.

In March 2022 enrollment was initiated in the randomized, double-blind, placebo-controlled Phase 1 study, which is being conducted in Australia. In July 2022 the company announced PK results from the single-ascending-dose portion of the study, which support once-daily dosing. Enrollment is now complete with the highest dose of the multiple-ascending-dose portion of the study.

To continue advancing the development of CC-42344, Cocrystal engaged a U.K.-based clinical research organization in August 2022 to conduct a human challenge Phase 2a study evaluating the antiviral activity safety and PK of CC-42344 in subjects infected with influenza A. This study will expose healthy volunteers to the virus in a controlled setting, which will significantly shorten the timeline for generating results.

“Completing enrollment in our Phase 1 study keeps us on track to announce topline results this year,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Results from this study will be incorporated into a regulatory submission to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct the human challenge Phase 2a study. Pending approval by the Agency, we expect initiation of the Phase 2a study in the second half of 2023.”