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Optimi Health Corp. announced plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted…
OPTHOptimi Health Corp.
Optimi Health Corp. announced plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for major depressive disorder (MDD). Authorized by Health Canada, the study will enroll up to 200 participants across multiple sites in Canada, with dosing expected to be completed by the end of 2027. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale total score from baseline. CEO Dane Stevens stated this represents the largest clinical commitment Optimi has made to date and that the company will supply its own naturally derived psilocybin manufactured at its GMP facility, retaining exclusive ownership of trial results. The company indicated it can comfortably fund the trial with current cash on hand. Optimi Health Corp. is a commercial-stage pharmaceutical manufacturer focused on producing and distributing regulated psychedelic drug products for mental health therapies.