Optimi Health plans 2027 Phase 3 MDMA PTSD trial
Optimi Health expands its psychedelic drug pipeline with a planned Phase 3 MDMA-assisted therapy trial for PTSD in up to 100 Canadian veterans and frontline workers.
Rhea-AI Filing Summary
Optimi Health Corp. (OPTH) reported that it plans to initiate a Health Canada-authorized Phase 3 clinical trial of MDMA-assisted therapy for post-traumatic stress disorder (PTSD), with the trial expected to begin in 2027. The study is intended to enroll up to 100 veterans and frontline workers at multiple Canadian sites and will use Optimi’s synthetic MDMA HCl in two supervised MDMA-plus-psychotherapy sessions per participant, spaced several weeks apart. The primary efficacy endpoint will be change in the CAPS-5 clinician-rated PTSD severity score. The company notes that the safety and efficacy of MDMA-assisted therapy for PTSD remain under investigation and that none of its MDMA products has market authorization from Health Canada, though its MDMA is being prescribed in Australia under that country’s Authorized Prescriber Scheme.
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Filing Explained
The filing additionally says Optimi’s MDMA products are accessible in Canada through the Special Access Program, while still lacking Health Canada market authorization; this is program-based access rather than general market approval.
Key Figures
Key Terms
Phase 3 clinical trial medical
MDMA-assisted therapy medical
Clinician-Administered PTSD Scale (CAPS-5) medical
Authorized Prescriber Scheme regulatory
Special Access Program regulatory
FAQ
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2026
Commission File Number: 001-43304
Optimi Health Corp.
(Translation of registrant's name into English)
269 David Brown Way
Princeton, B.C. V0X 1W0
Canada
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
EXHIBIT INDEX
| Exhibit | Description of Exhibit | |
| 99.1 | Press Release |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Optimi Health Corp. | ||
| (Registrant) | ||
| Date: September 16, 2026 | /s/ Dane Stevens | |
| Dane Stevens | ||
| Chief Executive Officer, Chief Marketing Officer and Director | ||
EXHIBIT 99.1
Optimi Health Expands Clinical Program with Phase 3 Trial Evaluating MDMA-Assisted Therapy for Post-Traumatic Stress Disorder
Health Canada-authorized trial to evaluate efficacy and safety of two sessions of MDMA-assisted therapy in up to 100 veterans and frontline workers
VANCOUVER, British Columbia, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) ("Optimi" or the "Company"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, announces 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 ("PTSD"). The trial is expected to begin in 2027.
The Phase 3 clinical trial 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. The primary efficacy endpoint will be change in the Clinician-Administered PTSD Scale (CAPS-5), the standard clinician-rated instrument for assessing PTSD severity.
"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. "PTSD and major depressive disorder 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. Psychedelic-assisted therapies have shown promise in helping patients find relief."
Post-traumatic stress disorder 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. Worldwide, an estimated 70% of people 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.
The safety and efficacy of MDMA-assisted therapy to treat PTSD are still 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.
About Optimi Health Corp.
Optimi Health Corp. 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. Optimi 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.
For more information, please visit optimi.net.
For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
(778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Investor Relations Contact:
CORE IR
ir@optimi.net
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including statements regarding the proposed clinical trial, the availability and enrolment of patients in the trial, the utilization of the data derived from the trial, and the ability to conduct evaluations as part of the trial, the potential benefits of MDMA, the Company’s ability to manufacture and ship products from its Canadian facility, and the Company’s positioning in the regulated psychedelic medicine market. Forward-looking statements and forward-looking information are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “may,” “will,” “would,” “could,” or similar expressions. Forward-looking statements and forward-looking information are based on several assumptions and are subject to a number of known and unknown risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Accordingly, there are or will be important factors that may cause actual results to differ from expected results. These factors include those described under “Risk Factors” in the Company’s registration statement on Form F-1, as amended, and other filings with the U.S. Securities and Exchange Commission made from time to time which are available at www.sec.gov and on SEDAR+ at www.sedarplus.ca and in the Company’s continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. These forward-looking statements reflect current expectations of management regarding future events and speak only as of the date of this press release. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.