Iryna Drozd
Cybin (NYSE:CYBN) said it plans to initiate a Phase 3 program in mid-year for its psychedelic-based therapy CYB003 in the treatment of major depressive disorder.
The drug developer said it and the FDA have aligned on the program’s design. Cybin plans to begin enrollment for a multinational multi-site Phase 3 program in mid-2024.
The program is currently targeting 15 U.S. testing sites, with Cybin hoping to add six in Europe. Cybin has hired Worldwide Clinical Trials as its contract research organization for the program.
Earlier this week, Cybin announced it had received FDA Breakthrough Therapy Designation for CYB003.
