The Phase 3 clinical trial is intended to enroll up to 100 participants across multiple sites in Canada, with enrollment focused on veterans and current or former frontline workers, including military, police, paramedics, firefighters and healthcare workers. Participants will receive the Company's synthetic MDMA HCl, supplied in two dosage formats, during two supervised sessions combining MDMA and psychotherapy, spaced several weeks apart, with follow-up evaluations after the final session. The primary efficacy endpoint will be change in the Clinician-Administered PTSD Scale (CAPS-5), the standard clinician-rated instrument for assessing PTSD severity.

"On the heels of announcing our Phase 2 trial of natural psilocybin for the treatment of major depressive disorder, we are preparing to advance our synthetic MDMA into an approved Phase 3 trial in PTSD, with the goal of submitting both products for registration," said Dane Stevens, Optimi's Chief Executive Officer and Co-Founder. "PTSD and major depressive disorder are large, underserved markets. Millions of patients around the globe continue to struggle despite existing treatments, and veterans and frontline workers carry a disproportionate share of that burden. Psychedelic-assisted therapies have shown promise in helping patients find relief."

Post-traumatic stress disorder is a mental health condition that can develop after experiencing or witnessing a terrifying, life-threatening, or deeply traumatic event. People with PTSD typically experience severe, persistent distress that significantly disrupts daily functioning. Worldwide, an estimated 70% of people will experience a traumatic event during their lifetime, with an estimated 3.9% of the global population developing the disorder. Many people with PTSD see limited benefit from first-line treatments such as trauma-focused psychotherapy and antidepressants, leaving a pressing need for new therapeutics.

The safety and efficacy of MDMA-assisted therapy to treat PTSD are still under investigation, and none of Optimi's MDMA drug products have received market authorization from Health Canada. Clinics in Australia have been prescribing MDMA manufactured by Optimi since October 2024.