Optimi Health to Launch Health Canada-Authorized Phase 3 Trial of MDMA-Assisted Therapy for PTSD
核心洞察
Optimi Health plans a Health Canada-authorized Phase 3 trial of synthetic MDMA-assisted therapy for PTSD, expected to begin in 2027 across multiple Canadian sites.
The trial aims to enroll up to 100 veterans and current or former frontline workers, including military personnel, police, paramedics, firefighters and healthcare workers.
Participants will receive synthetic MDMA HCl in two dosage formats during two supervised sessions combining MDMA with psychotherapy, spaced several weeks apart.
Optimi Health Corp. (搜索) (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) announced plans to initiate a Health Canada-authorized Phase 3 clinical trial evaluating MDMA (3,4-methylenedioxymethamphetamine)-assisted therapy for individuals with post-traumatic stress disorder (搜索) (PTSD). The trial is expected to begin in 2027.
The Phase 3 study is intended to enroll up to 100 participants across multiple sites in Canada, with enrollment focused on veterans and current or former frontline workers, including military, police, paramedics, firefighters and healthcare workers. Participants will receive the company's synthetic MDMA HCl, supplied in two dosage formats, during two supervised sessions combining MDMA and psychotherapy, spaced several weeks apart, with follow-up evaluations after the final session.
Endpoint and Trial Design
The primary efficacy endpoint will be change in the Clinician-Administered PTSD Scale (CAPS-5), described as the standard clinician-rated instrument for assessing PTSD severity. The company said its synthetic MDMA will be supplied for the planned Phase 3 trial, and the program is intended to generate clinical data supporting potential registration of the product.
The planned Phase 3 program follows Optimi's recently announced Phase 2 trial evaluating natural psilocybin for major depressive disorder (搜索). "On the heels of announcing our Phase 2 trial of natural psilocybin for the treatment of major depressive disorder, we are preparing to advance our synthetic MDMA into an approved Phase 3 trial in PTSD, with the goal of submitting both products for registration," said Dane Stevens, Optimi's Chief Executive Officer and Co-Founder.
Unmet Need in PTSD
PTSD is a mental health condition that can develop after experiencing or witnessing a terrifying, life-threatening, or deeply traumatic event. People with PTSD typically experience severe, persistent distress that significantly disrupts daily functioning. According to the company, an estimated 70% of people worldwide will experience a traumatic event during their lifetime, with an estimated 3.9% of the global population developing the disorder.
Many people with PTSD see limited benefit from first-line treatments such as trauma-focused psychotherapy and antidepressants, leaving a pressing need for new therapeutics. "PTSD and major depressive disorder (搜索) are large, underserved markets. Millions of patients around the globe continue to struggle despite existing treatments, and veterans and frontline workers carry a disproportionate share of that burden," Stevens said. "Psychedelic-assisted therapies have shown promise in helping patients find relief."
Regulatory Status and Manufacturing
The safety and efficacy of MDMA-assisted therapy to treat PTSD remain under investigation, and none of Optimi's MDMA drug products have received market authorization from Health Canada. Clinics in Australia have been prescribing MDMA manufactured by Optimi since October 2024.
Optimi Health Corp. (搜索) is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. The company supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country's Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.
Following the announcement, Optimi shares (OPTH) were reported trading at $4.84, down 5.56%.