Optimi Health Celebrates Encouraging Results from the MAPS Phase 3 MDMA-Assisted Therapy Clinical Trial
- The Phase 3 trial shows significant reduction in PTSD symptoms and functional impairment
- Participants undergoing MDMA-AT displayed a marked improvement in functionality with a mean change of -3.3 compared to -2.1 in the placebo group
- The trial emphasizes the general safety of the MDMA-AT approach
- None.
VANCOUVER, British Columbia, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelics drug research and formulation company, is pleased to see the positive and encouraging outcomes from the MAPS Phase 3 MDMA-Assisted Therapy (MDMA-AT) Clinical Trial published today on Nature Medicine. The Company considers the results to be a substantial step forward in the treatment of individuals grappling with moderate to severe Post-Traumatic Stress Disorder (PTSD). The study, conducted across multiple sites, showcases the potential of MDMA-AT to significantly reduce PTSD symptoms and functional impairment, indicating it as a promising therapeutic avenue.
The randomized, double-blind, confirmatory Phase 3 study focused on the assessment of the efficacy and safety of MDMA-assisted therapy in comparison to placebo with identical therapy. This groundbreaking trial was notably diverse, including a significant representation from the Hispanic/Latino community (
Moreover, the participants undergoing MDMA-AT displayed a marked improvement in functionality, as measured by the Sheehan Disability Scale (SDS) functional impairment score, with a mean change of -3.3 compared to -2.1 in the placebo group, also showcasing statistical significance with P=0.03 and a moderate effect size (d=0.4).
An encouraging aspect of the trial outcomes is the general tolerability of the treatment. While seven participants experienced a severe treatment emergent adverse event (TEAE), there were no deaths or serious TEAEs reported, emphasizing the general safety of the MDMA-AT approach.
"We are truly heartened by the indications from the trial that MDMA-AT stands as a beacon of hope, potentially serving as a transformative tool in alleviating the distress and impairment witnessed in individuals battling moderate to severe PTSD," said Optimi CEO Bill Ciprick. "It could open new doors and foster hope where it is much needed."
Optimi gratefully acknowledges the participants, clinicians, and all involved who have played a crucial role in bringing this pioneering study to fruition. For further details on the study, please refer to the ClinicalTrials.gov identifier: NCT04077437.
For further information or to request an interview, please contact:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is an end-to-end Canadian-based drug researcher and formulator licensed by Health Canada to produce and supply psychedelic substances such as 3,4-Methylenedioxymethamphetamine (“MDMA”) and natural, GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi’s products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA producer in North America.
FORWARD-LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’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. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 9, 2023, and other continuous disclosure filings available under Optimi’s profile at www.sedarplus.ca. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such 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 news release are expressly qualified in their entirety by this cautionary statement.
