Cocrystal Pharma, Inc. announced 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 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.