Optimi Health Corp. (NASDAQ: OPTH) has announced plans to launch a Phase 2 clinical trial for major depressive disorder (MDD), authorized by Health Canada. The trial, which is expected to start in the first half of 2027 and conclude by the end of the same year, will involve up to 200 participants across multiple sites in Canada.
The trial will evaluate the safety and efficacy of a single supervised dose of naturally derived psilocybin, manufactured at Optimi's GMP facility. The primary efficacy endpoint will be the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline. Periodic interim safety and efficacy readouts will be provided, with full topline results available after dosing and follow-up evaluations are completed for all participants.
Optimi Health holds a Drug Establishment Licence in Canada and supplies psilocybin through Health Canada's Special Access Program. The company's psilocybin drug products have not received market authorization by Health Canada. Major depressive disorder affects an estimated 332 million people worldwide, according to data from the World Health Organization.
Dane Stevens, Chief Executive Officer and Co-Founder of Optimi Health, stated that this 200-subject Phase 2 trial is the largest clinical commitment the company has made to date. Optimi has exclusive ownership of the trial results and can fund the trial using its current cash on hand.
