BOTHELL, WA, USA I October 06, 2021 I 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 resulted in 9 million to 45 million illnesses in the U.S. annually, resulting in 140,000 to 810,000 hospitalizations and 12,000 to 61,000 deaths.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
SOURCE: Cocrystal Pharma
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BOTHELL, WA, USA I October 06, 2021 I 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 resulted in 9 million to 45 million illnesses in the U.S. annually, resulting in 140,000 to 810,000 hospitalizations and 12,000 to 61,000 deaths.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
SOURCE: Cocrystal Pharma
Post Views: 69
