COCP - Cocrystal Pharma submits pre-IND package to FDA for COVID-19 candidate

Cocrystal Pharma (NASDAQ:COCP) has added ~5.5% in the pre-market after the company disclosed the submission of a pre-Investigational New Drug (IND) briefing package to the FDA seeking to advance its experimental protease inhibitor CDI-45205 for the treatment of COVID-19. “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,” the company’s co-interim CEO/President Sam Lee noted. The response from the regulator is expected to give more clarity and guidance on the design of Phase 1 and 2 clinical trials for CDI-45205. In July, Cocrystal (COCP) shared in vitro data for CDI-45205 to indicate its effectiveness against SARS-CoV-2 Delta (India/B.1.617.2) and Gamma (Brazil/P.1) variants.

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Cocrystal Pharma submits pre-IND package to FDA for COVID-19 candidate