Recent Updates — OPTH
Optimi Health Corp. completed a batch of MDMA finished drug product at its GMP facility in British Columbia, expected to support three programs: a proposed Phase 3 clinical trial in Canada enrolling up to 100 veterans and frontline workers for PTSD treatment; a clinical trial in Israel partnered with MAPS; and commercial exports to Australia planned before year-end. The Canadian trial aims to evaluate efficacy using the CAPS-5 scale, with initiation expected in 2027. In Australia, MDMA is prescribed under an Authorised Prescriber Scheme with reimbursement from public and private payers. Optimi Health Corp. operates as a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products for mental health therapies.
Optimi Health Corp. announced on September 29, 2026, that Melanie Pump has been appointed to its Board of Directors. Ms. Pump is a seasoned finance executive with over 25 years of experience in technology and fintech, currently serving as CFO of Qu Data Centres. Concurrently, Leah Hodges resigned as Corporate Secretary, and CEO Dane Stevens was appointed to fill the role. Optimi Health Corp. operates as a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies.
Optimi Health Corp. completed and quality-released a cGMP batch of 5mg naturally derived psilocybin capsules manufactured at its Princeton, British Columbia facility under a Health Canada Drug Establishment Licence. This single batch supplies both the company's recently announced Phase 2 clinical trial for major depressive disorder (MDD) in Canada and commercial customers in Australia. The Canadian trial is a multisite, open-label study of up to 200 participants receiving a single supervised dose, with patient dosing expected to conclude by the end of 2027. In Australia, the product is prescribed for treatment-resistant depression under the Therapeutic Goods Administration's Authorised Prescriber Scheme and reimbursed by various public and private payers. Optimi has supplied this psilocybin product commercially in Australia since 2025 with no reported serious adverse events. The company operates as a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products for mental health therapies.
Optimi Health Corp. appointed Dr. Michael Blough as its new Chief Clinical Development Officer on September 22, 2026. In this newly created role, Dr. Blough will oversee the company's clinical development strategy and operations for its planned Phase 2 psilocybin trial in major depressive disorder and Phase 3 MDMA trial in PTSD. The appointment supports protocol execution, site activation, and Health Canada interactions as both trials are expected to begin enrolling patients next year. Optimi Health Corp. is a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products for mental health therapies.
Optimi Health Corp. announced plans to initiate a Phase 3 clinical trial evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The Health Canada-authorized study is expected to begin in 2027 and will enroll up to 100 participants, primarily veterans and frontline workers such as military personnel, police, paramedics, firefighters, and healthcare workers. Participants will receive the company's synthetic MDMA HCl during two supervised sessions combined with psychotherapy. The primary efficacy endpoint is the change in Clinician-Administered PTSD Scale (CAPS-5) scores. This follows a recent announcement regarding a Phase 2 trial for natural psilocybin in major depressive disorder, as management aims to submit both products for registration. Optimi Health Corp. operates in the pharmaceutical industry, specifically manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies.