Cybin’s depressive disorder candidate meets Phase 2 efficacy endpoint

Cybin announced Phase 2 interim results for CYB003, its proprietary deuterated psilocybin analog, demonstrating a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo. At the 3-week primary efficacy endpoint, the reduction in major depressive disorder symptoms was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points. Values less than 0.05 are considered statistically significant and values less than 0.001 are considered highly statistically significant. Cybin expects to share the full complement of topline data later this quarter, and 12-week durability data in Q1 2024. CYB003 was well tolerated with no drug-related Serious Adverse Events. Cybin plans to submit this topline data to the FDA and request an end of Phase 2 meeting to be held in Q1 2024. Recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of Q1 2024.