A clinical path to registration.
Optimi is advancing two Health Canada-authorized clinical trials of its own drug products: a Phase 2 study of natural psilocybin-assisted therapy for major depressive disorder, and a Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder. Both are expected to begin enrollment in 2027.
The trials build on Optimi's commercial foundation: a Health Canada Drug Establishment Licence, GMP manufacturing of both molecules, and active supply to regulated access programs in Australia and Canada.
- Design
- Single supervised session combining natural psilocybin and psychotherapy
- Participants
- Up to 200
- Sites
- Multiple sites in Canada
- Timing
- Enrollment to begin 1H 2027; dosing complete by end of 2027
- Primary efficacy endpoint
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
- Design
- Two supervised sessions combining MDMA and psychotherapy
- Participants
- Up to 100, with a focus on veterans and frontline workers
- Sites
- Multiple sites in Canada
- Timing
- Enrollment to begin in 2027
- Primary efficacy endpoint
- Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Own drug, own data
Optimi supplies its own GMP-manufactured drug product to both trials and holds exclusive ownership of the results, the datasets intended to support registration.
Natural-API differentiation
Most clinical-stage developers use synthetic psilocybin. Optimi's Phase 2 study evaluates naturally extracted psilocybin, among the largest studies of naturally derived psilocybin to date.
Commercial today
Unlike most drug developers, Optimi already supplies both molecules to authorized prescribers in Australia and through Canada's Special Access Program, generating revenue while the trials run.
1. McIntyre RS, et al. World Psychiatry. 2023;22(3):394–412. 2. Company estimates derived from various sources.
Dr. Michael Blough
Chief Clinical Development Officer
Medical researcher with 20+ years directing research programs spanning bench science, pre-clinical studies, and clinical trials. Led the development and Health Canada authorization of multiple clinical trials of psilocybin and MDMA for PTSD and treatment-resistant depression, and has worked with Optimi on clinical trial applications since 2022. Previously spent 15 years in brain cancer research, publishing 30+ peer-reviewed papers and leading a seven-year Terry Fox Research Institute national initiative. Oversees Optimi's Phase 2 and Phase 3 clinical programs.
The safety and efficacy of psilocybin- and MDMA-assisted therapy are still under investigation. No regulatory authority has approved psilocybin or MDMA as a marketed prescription medicine in the United States or Canada. Trial timing and design are forward-looking and subject to change; see the Company's continuous disclosure filings for risk factors.