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Optimi Health plans Phase 3 MDMA-assisted therapy trial for PTSD starting 2027 with up to 100 participants
OPTHOptimi Health Corp.
Optimi Health Corp. announced plans to initiate a Phase 3 clinical trial evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The Health Canada-authorized study is expected to begin in 2027 and will enroll up to 100 participants, primarily veterans and frontline workers such as military personnel, police, paramedics, firefighters, and healthcare workers. Participants will receive the company's synthetic MDMA HCl during two supervised sessions combined with psychotherapy. The primary efficacy endpoint is the change in Clinician-Administered PTSD Scale (CAPS-5) scores. This follows a recent announcement regarding a Phase 2 trial for natural psilocybin in major depressive disorder, as management aims to submit both products for registration. Optimi Health Corp. operates in the pharmaceutical industry, specifically manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies.