Cybin Inc. (CYBN) made a public announcement on Thursday regarding a successful End-of-Phase 2 meeting with the FDA. This meeting pertains to CYB003, Cybin's deuterium-enriched psilocybin analog intended as an additional treatment for Major Depressive Disorder.
Cybin Inc. is currently in the clinical development phase. This successful meeting marks the initiation of the worldwide first Phase 3 deuterium-enriched psilocybin analog depression study, following the successful completion of the Phase 2 study.
The company is aiming to open registration for a multinational and multisite Phase 3 program in mid-2024. This decisive Phase 3 program will include two rigorous and properly controlled studies, along with a long-term extension.