Optimi Health Plans To Initiate A Phase 3 Clinical Trial Evaluating MDMA-Assisted Therapy For PTSD Authorized By Health Canada; Trial Is Expected To Begin In 2027

Optimi Health plans to initiate a Phase 3 clinical trial for MDMA-assisted therapy targeting PTSD, authorized by Health Canada, with the trial expected to begin in 2027. The trial aims to enroll up to 100 participants, focusing on veterans and frontline workers, and will assess the therapy's efficacy using the Clinician-Administered PTSD Scale (CAPS-5). This follows the company's Phase 2 trial of natural psilocybin for major depressive disorder. Currently, none of Optimi's MDMA products have received market authorization from Health Canada.