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Cocrystal Pharma Receives Australian Regulatory Clearance to Initiate Phase 1 Study of CC-42344 for the Treatment of Pandemic and Seasonal Influenza
BOTHELL, Wash., Oct. 06, 2021 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company
About this update from Cocrystal Pharma, Inc.
[{"type":"text","content":"BOTHELL, Wash., Oct. 06, 2021 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of coronaviruses, influenza, hepatitis C viruses and noroviruses, 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 randomized, double-blind, placebo-controlled 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. CC-42344 binds to a highly conserved PB2 site of influenza polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. 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. “The need for a novel, broad-spectrum, oral antiviral for pandemic and seasonal influenza A is clear as current approved influenza treatments are partially effective and are prone to viral resistance,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “We discovered CC-43244 using our proprietary structure-based drug discovery platform technologies. CC-43244 is specifically designed to be effective against pandemic and seasonal influenza A strains and emerging avian influenza viruses.” “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,” added James Martin, Cocrystal’s CFO and co-interim CEO. “We are delighted to begin our first clinical study with CC-42344 as a treatment for this major global health concern.” The World Health Organization (WHO) estimate there are approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 290,000 to 650,000 deaths. The Center for Disease Control (CDC) estimates that since 2010 influenza has resu...