Cocrystal Pharma (NASDAQ:COCP)announces receipt of clearance from an Australian Human Research Ethics Committee (HREC) to initiate a Phase 1 trial with its orally administered PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A.
The Phase 1 study is expected to enroll 56 healthy volunteers at a single site in Australia. The study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344.
In preclinical testing, CC-42344 demonstrated excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu and Xofluza-resistant strains, as well as favorable pharmacokinetic and drug-resistance profiles.
“Our decision to conduct the Phase 1 trial in Australia was due to favorable regulatory policies and a clinical trial environment that aligns with our strategy for rapid, cost-efficient and high-quality clinical development,” said James Martin, Cocrystal’s CFO and co-interim CEO.