Cybin Inc. announced positive Phase 2 topline safety and efficacy data for CYB003, its proprietary deuterated psilocybin analog, being developed for the treatment of major depressive disorder (?MDD?). Summary of CYB003 Phase 2 topline efficacy data: Rapid and large improvements in symptoms of depression observed after single doses of CYB003?: An average of 13.75 points on MADRS (12mg and 16mg cohorts pooled) which is statistically significant from placebo at 3 weeks (p<0.0001) (n=34 total: n=24 on CYB003; n=10 on placebo). Clear incremental benefit of a second dose?: Incremental and sustained benefit seen as a further 5.8 point improvement on the MADRS total score with a second dose of CYB003 (12mg) at 6 weeks?.
79% of patients were responsive to treatment and 79% of patients were in remission from their depression at 6 weeks after receiving two doses of CYB003 (12mg) (n=32 total: n=22 on CYB003; n=10 on placebo). Magnitude of improvement far superior compared to approved antidepressants and recently reported data with? other psychedelics?: Effects translate into unprecedented effect size (Cohen?s d > 2) (SSRIs = 0.243).
These results compare favorably to pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake inhibitors (?SSRIs?), submitted to U.S. Food and Drug Administration (?FDA?) which show an average improvement of 1.82 points on the MADRS total score vs. placebo.Data support progression to a Phase 3 study Safety and tolerability: CYB003 has demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to? moderate and self?limiting.
Cybin plans to submit topline data to the U.S. Food and Drug Administration (?FDA?) and request an end of Phase 2 meeting to be held in first quarter of 2024. Additional 12-week durability data from the Phase 2 CYB003 study is anticipated in first quarter of 2024. Recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of first quarter of 2024.