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Cocrystal Pharma Submits Pre-Investigational New Drug Briefing Package to the FDA for Clinical Development Guidance of CDI-45205 for COVID-19 Treatment
FDA’s response is expected to provide greater clarity and guidance on designing Phase 1 and Phase 2 clinical trials for CDI-45205 BOTHELL, Wash., Nov. 01,
About this update from Cocrystal Pharma, Inc.
[{"type":"text","content":"FDA’s response is expected to provide greater clarity and guidance on designing Phase 1 and Phase 2 clinical trials for CDI-45205 BOTHELL, Wash., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the submission of a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its broad-spectrum protease inhibitor CDI-45205 for the treatment of patients with COVID-19. “The pre-IND submission is a critical step to obtain the FDA’s guidance on preclinical studies, manufacturing, toxicology, and clinical development plans for CDI-45205. We look forward to our communication with the FDA and advancing toward Phase 1 and Phase 2 clinical trials to address the unmet needs of patients and to contribute to global efforts to end this pandemic,” said Sam Lee, Ph.D., Cocrystal’s co-interim CEO and President. “As with all of our antiviral candidates, we are exploring multiple routes of administration including oral, inhalation, and injection,” added Dr. Lee. “We anticipate that CDI-45205 is best suited for intranasal/pulmonary administration based on its novel mechanism of action and pharmacokinetic profile, with this route having the advantage of direct delivery to the respiratory system, a primary infection site for SARS-CoV-2. We are also advancing preclinical studies with our novel oral COVID-19 protease inhibitors developed using our proprietary structure-based drug discovery technology, and are very excited about potential multiple treatment options for COVID-19.” “A number of drugs are being developed as COVID-19 treatments that were originally designed for other indications. These repurposed drugs or drug candidates are a good start for humanity, but likely not the best-in-class solution that will end the pandemic,” said James Martin, Cocrystal’s co-interim CEO and CFO. “Our drug candidates are specifically designed to target the viral replication enzymes and protease, which we believe makes it possible to develop effective treatments for COVID-19 and its variants.” About CDI-45205 CDI-45205 is among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (...