Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A
Feedback provides greater clarity on regulatory requirements for planned Phase 2b trial
BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq:COCP) (“Cocrystal” or the “Company”) announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical steps such as the proposed clinical trial design, as well as clinical drug manufacturing and nonclinical studies deemed necessary before filing the trial design. The feedback was provided in a written response to a Pre-IND package and questions submitted by the Company in January 2024.