Phase 2a Enrollment Completed for Cocrystal Pharma's Oral Antiviral CC-42344 for Influenza

BOTHELL, Wash., May 01, 2024 - Cocrystal Pharma, Inc. (Nasdaq: COCP) has announced the completion of enrollment for a Phase 2a clinical study aimed at evaluating its novel antiviral, CC-42344, for the treatment of influenza A. This randomized, double-blind, placebo-controlled trial involved 78 subjects who were infected with influenza A and aims to assess the safety, tolerability, and antiviral efficacy of CC-42344. The new drug is a PB2 inhibitor designed to disrupt a crucial step in the viral replication process of both pandemic and seasonal influenza A. The discovery of this drug was made using Cocrystal's proprietary structure-based drug discovery platform technology.

Dr. Sam Lee, the President and co-CEO of Cocrystal, expressed satisfaction with the timely completion of the study enrollment. He emphasized the urgent need for effective treatments targeting highly pathogenic pandemic and seasonal influenza strains. The successful enrollment keeps the company on track to release topline results later this year. Conducted in the United Kingdom, the human challenge study was designed to evaluate CC-42344's safety profile, virological impacts, and potential to alleviate clinical symptoms in patients, positioning it as a promising oral treatment for various influenza A strains.

Earlier this year, in March 2024, Cocrystal received positive feedback from the FDA on the Pre-Investigational New Drug (Pre-IND) application for CC-42344. The FDA provided guidance on the design of a proposed Phase 2b study protocol, which aims to further evaluate the drug as a potential oral treatment for influenza A.

Cocrystal also has plans to initiate a Phase 1 study in Australia to test an inhaled formulation of CC-42344. This new formulation will be evaluated for its potential to treat influenza A and act as a post-exposure prophylaxis. Preclinical data indicate that the inhaled version of CC-42344 achieves effective lung delivery, superior lung exposure, and has shown efficacy in treating influenza-infected human lung cells, along with exhibiting a favorable safety profile.

In December 2023, Cocrystal marked an important milestone with the first-patient-in for the Phase 2a human challenge clinical trial of CC-42344. This investigational oral antiviral aims to treat both pandemic and seasonal influenza A. The study, which is randomized, double-blind, and placebo-controlled, was designed to evaluate various safety and efficacy parameters in subjects treated with CC-42344. A total of 78 healthy individuals were enrolled in this study.

In late 2022, Cocrystal reported positive safety and tolerability outcomes from the single-ascending and multiple-ascending dose portions of a Phase 1 trial conducted on healthy volunteers in Australia. Preclinical studies have demonstrated that CC-42344 is highly effective against multiple strains of both seasonal and pandemic influenza A.

Seasonal influenza poses a significant global health challenge, with approximately 1 billion cases reported worldwide each year, resulting in 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. In the United States, around 8% of the population is affected by influenza each season, leading to approximately $10.4 billion in direct costs associated with hospitalizations and outpatient visits.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology firm focused on developing novel antiviral therapeutics targeting the replication mechanisms of various viruses, including influenza, coronaviruses, noroviruses, and hepatitis C. Utilizing unique structure-based drug discovery technologies and Nobel Prize-winning expertise, Cocrystal aims to develop first- and best-in-class antiviral drugs.