ocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205
BOTHELL, Wash., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces receipt of guidance from the U.S. Food and Drug Administration (FDA) for the further development of CDI-45205, Cocrystal’s novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The FDA’s guidance was received in a written response to Cocrystal’s pre-Investigational New Drug (IND) briefing package that was submitted in October 2021.
“The FDA’s response contained extensive and valuable responses to a list of questions we proposed in our pre-IND briefing package, providing key insights on advancing the non-clinical and clinical development of CDI-45205,” said Sam Lee, Ph.D., President and interim co-CEO of Cocrystal. “The FDA’s guidance marks an important milestone in our continued development of CDI-45205. We now have a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.”
The FDA’s response covered topics including preclinical studies, manufacturing, pharmacology and toxicology, and clinical development plans for CDI-45205 for Phase 1 and Phase 2 studies. In preparation for clinical development, Cocrystal intends to conduct CDI-45205 formulation development, IND-enabling studies and virology assessments, as well as API drug manufacturing for use in preclinical and clinical studies.
CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also in 2022 with an orally administered main protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.
“Our COVID-19 programs feature novel inhibitors that are specifically designed to block viral replication of SARS-CoV-2,” said James Martin, Cocrystal’s CFO and interim co-CEO. “Our inhibitors have shown antiviral activity against various SARS-CoV-2 variants to date, including the Alpha, Beta, Gamma and Delta variants, and now even the Omicron variant. CDI-45205 is not a quick-to-market repurposed drug. Because of its design, we remain highly confident in the broad-spectrum antiviral ability of our compound CDI-45205 in addressing SARS-CoV-2 and variants.”
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