Optimi Health Corp. announced the positive and encouraging outcomes from the MAPS Phase 3 MDMA-Assisted Therapy (MDMA-AT) Clinical Trial published 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 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.

Optimi gratefully acknowledges the participants, clinicians, and all involved who have played a crucial role in bringing this pioneering study to fruition.