Health Canada-authorized trial to evaluate a single supervised dose of natural psilocybin, with dosing expected to be completed by the end of 2027

Up to 200 participants at sites across Canada, among the largest studies of naturally derived psilocybin to date

VANCOUVER, British Columbia, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Optimi Health Corp. (NASDAQ:OPTH) ("Optimi" or the "Company"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD"). The trial is planned to be initiated in the first half of 2027, with dosing expected to be complete by the end of 2027.

The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind.