Phase 2a Enrollment Complete for Cocrystal's Influenza Antiviral CC-42344

Cocrystal Pharma, a clinical-stage biotechnology firm, has completed enrollment for a Phase 2a clinical trial of its oral PB2 inhibitor, CC-42344, aimed at treating influenza A. The study, involving 78 subjects, is a randomized, double-blind, placebo-controlled human challenge trial assessing the drug's safety, tolerability, and efficacy against the virus. The company's proprietary platform technology facilitated the discovery of this broad-spectrum antiviral, which targets a crucial step in viral replication and transcription.

The urgency for new antiviral treatments is highlighted by the need to combat highly pathogenic avian influenza strains. Sam Lee, Ph.D., President and co-CEO of Cocrystal, expressed satisfaction with the timely enrollment completion, which aligns with the company's plan to announce preliminary results later in the year. The study, conducted in the UK, is designed to evaluate the drug's impact on clinical symptoms and its safety profile.

In March 2024, Cocrystal received positive feedback from the FDA, guiding the design of a proposed Phase 2b study protocol for CC-42344. Additionally, the company plans to initiate a Phase 1 study in Australia to explore an inhaled formulation of the drug as a potential influenza treatment and post-exposure prophylaxis. Preclinical data indicates that the inhaled version of CC-42344 shows promising lung exposure and efficacy against influenza in human lung epithelia, along with a favorable safety profile.

Cocrystal announced the Phase 2a trial's first patient in December 2023, focusing on the safety and clinical measurements of influenza A infection in subjects treated with oral CC-42344. The company also reported favorable safety and tolerability results from the Phase 1 trial conducted in Australia in late 2022, with preclinical data demonstrating the drug's high activity against both seasonal and pandemic influenza A strains.

Seasonal influenza poses a significant global health challenge, with approximately 1 billion cases annually, severe illnesses affecting 3-5 million individuals, and causing up to 650,000 deaths, according to the World Health Organization. In the U.S., influenza affects about 8% of the population each season and incurs approximately $10.4 billion in direct medical costs annually.

Cocrystal Pharma is dedicated to discovering and developing innovative antiviral therapeutics targeting a range of viruses, including influenza, coronaviruses, noroviruses, and hepatitis C. The company utilizes structure-based technologies and expertise from Nobel Prize winners to create leading antiviral drugs. For more information, visit www.cocrystalpharma.com.