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Optimi Health Corp
Symbol OPTI
Shares Issued 87,038,441
Close 2023-09-14 C$ 0.19
Market Cap C$ 16,537,304
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Optimi Health cheers phase 3 MAPS PTSD trial results

2023-09-14 16:18 ET - News Release

Mr. Bill Ciprick reports

OPTIMI HEALTH CELEBRATES ENCOURAGING RESULTS FROM THE MAPS PHASE 3 MDMA-ASSISTED THERAPY CLINICAL TRIAL

Optimi Health Corp. is cheering the positive and encouraging outcomes from the MAPS (Multidisciplinary Association for Psychedelic Studies) phase 3 MDMA (3,4-methylenedioxy-N-methamphetamine)-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 posttraumatic 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 with placebo with identical therapy. This groundbreaking trial was notably diverse, including a significant representation from the Hispanic/Latino community (26.9 per cent) and individuals identifying as other than white (33.7 per cent), presenting a comprehensive insight into the therapy's effectiveness across a broad spectrum of individuals.

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 minus-3.3 compared with minus-2.1 in the placebo group, also showcasing statistical significance with P equals 0.03 and a moderate effect size (d equals 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 Bill Ciprick, Optimi chief executive officer. "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 website, identifier: NCT04077437.

About Optimi Health Corp.

Optimi Health is an end-to-end drug researcher and formulator licensed by Health Canada to produce and supply psychedelic substances such as 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 No. 1 trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, B.C., making it the largest psilocybin and MDMA producer in North America.

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