VANCOUVER, British Columbia, Sept. 14, 2023 (GLOBE NEWSWIRE) — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelic drug research and formulation company, is pleased to see positive and encouraging results from its Phase III clinical trial of MDMA-assisted therapy (MDMA-AT) published today in Nature Medicine. The company sees the results as a major step forward in treating individuals with moderate to severe post-traumatic stress disorder (PTSD). The study, conducted across multiple sites, shows that MDMA-AT can significantly reduce PTSD symptoms and functional impairment, suggesting it is a promising treatment modality.
This randomized, double-blind, confirmatory phase III study focused on evaluating the efficacy and safety of MDMA-assisted treatment compared to placebo with identical treatment. This pilot trial was remarkably diverse, including significant representation from the Hispanic/Latino community (26.9%) and individuals identifying as non-white (33.7%), providing a comprehensive view of the treatment’s effectiveness across a broad range of individuals.
Furthermore, participants who underwent MDMA-AT showed significant improvement in functional performance, as measured by the functional impairment score on the Sheehan Disability Scale (SDS), with an average change of -3.3 compared to -2.1 in the placebo group. They also showed statistical significance with P = 0.03 and a moderate effect size (d = 0.4).
One encouraging aspect of the trial results is the overall tolerability of the treatment. While seven participants experienced a treatment-emergent acute adverse event (TEAE), no deaths or serious adverse events were reported, underscoring the overall safety of the MDMA-AT approach.
“We are truly encouraged by indications from the trial that MDMA-AT represents a beacon of hope, potentially serving as a transformative tool in alleviating the distress and vulnerability experienced by individuals with ADHD,” said Bill Siebrick, CEO of Optimi. Moderate to severe post-traumatic stress disorder. “It can open new doors and promote hope where it is needed most.”
Optimi extends its thanks and gratitude to the participants, clinicians and all participants who played a crucial role in making this pioneering study possible. For more details about the study, please refer to ClinicalTrials.gov Identifier: NCT04077437.
www.optimihealth.ca
For more information or to request an interview, please contact:
Michael Kidd
Investor relations
e-mail: investors@optimihealth.ca
Phone: +1 (902) 880 6121
About Optitime (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health, Inc. is a Canadian-based pharmaceutical researcher and manufacturer, licensed by Health Canada to produce and supply psychedelics such as 3,4-methylenedioxymethamphetamine (“MDMA”) and GMP grade natural psilocybin, as well. Such as Functional Mushrooms, which focuses on the health and wellness markets. Created with the goal of producing scalable drug formulations for transformative human trials, the company’s goal is to be the premier trusted and compassionate supplier of safe drug products worldwide. Optimi’s products are grown in its two facilities totaling 20,000 square feet in Princeton, British Columbia, making it the largest producer of psilocybin and ecstasy in North America.
Forward-looking statements
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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 Optitime’s control, which could cause actual results and events to differ materially from those disclosed or implied by such statements. Forward-looking statements. These risks and uncertainties include, but are not limited to, the impact and development of the COVID-19 pandemic and other factors set forth in the “Forward-Looking Statements” and “Risk Factors” in the Company’s Annual Information Form dated January 9, 2023, and other ongoing disclosure filings available under Definition of Optimi on 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 required by law. New factors emerge from time to time, and Optimi cannot 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 expressed in any forward-looking statement.
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