Cybin completes dosing in Cohort 5 in Phase 2 trial of CYB003

Cybin announced that its Phase 2 trial evaluating CYB003, an investigational proprietary deuterated analog of psilocybin for the potential treatment of major depressive disorder, or MDD, has completed dosing in Cohort 5 with no serious adverse events or other adverse events that may preclude continued dosing. The completed Cohorts 4 and 5 evaluated two 12mg doses of CYB003, and recruitment is underway to commence dosing for Cohort 6, the final cohort in the Phase 2 portion of the study. To date, CYB003 has demonstrated a favorable safety and tolerability profile with no serious adverse events reported at the doses evaluated. Interim findings from the Phase 1/2a study have also demonstrated positive observations, showing that CYB003 dosing led to a rapid and robust psychedelic response in participants at low doses, while maintaining a safe and well-tolerated therapeutic profile. Upcoming milestones for the CYB003 program: Completion of CYB003 dosing in MDD cohorts expected in Q3; Topline efficacy data readout from CYB003 Phase 2 clinical trial expected in Q3/Q4; FDA submission of CYB003 Phase 1/2a data for pivotal studies expected following topline efficacy data readout.