September 14, 2023 — 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 (26.9%) and individuals identifying as other than White (33.7%), 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 -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.
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.