Optimi Health to supply MDMA for MAPS Israel PTSD trial

Executive Summary

• Optimi Health Corp. has been selected as the supplier for MDMA capsules for MAPS Israel's "Healing October 7" clinical trial, which has received formal approval from the Israeli Ministry of Health.
• The trial is an open-label, multicentre, non-inferiority study evaluating the safety and effectiveness of individual versus group MDMA-assisted therapy for PTSD in patients diagnosed following the October 7 collective trauma.
• Optimi has completed the first export of its Good Manufacturing Practice (GMP) 40 mg and 60 mg MDMA capsules to Israel to support the study, which is sponsored by Sheba Medical Center and conducted at two clinical sites.

Key Details

• Parties Involved: Optimi Health Corp. (Supplier) and MAPS Israel (Sponsor/Conductor).
• Trial Name: Healing October 7 project.
• Regulatory Status: Formal approval granted by the Israeli Ministry of Health.
• Study Design: Open-label, multicentre, non-inferiority study.
• Objective: Evaluate safety and effectiveness of individual vs. group MDMA-assisted therapy for PTSD in the context of recent collective trauma.
• Enrollment: 168 participants total; initial approval granted for the first 20 patients.
• Dosage/Supply: Participants will receive three MDMA-assisted therapy sessions supported by Optimi's GMP 40-milligram and 60 mg MDMA capsules.
• Clinical Sites:
  • Sheba Medical Center (Sponsor).
  • Lev Hasharon Mental Health Centre.
  • Be'er Sheva Mental Health Centre.
• Logistics: Optimi has completed the first export of GMP capsules to Israel.
• Company Background: Optimi is a Canadian GMP-compliant pharmaceutical manufacturer licensed by Health Canada for handling controlled substances, with facilities in British Columbia.

Notable Quotes

• Dr. Revital Amiaz, Head of Psychiatry at Sheba Medical Center: "MDMA-assisted therapy offers a meaningful clinical advantage in treating PTSD. Unlike traditional approaches that focus on exposure or symptom management, MDMA reduces fear and emotional reactivity, allowing patients to process traumatic memories more effectively and achieve more durable improvement."
• Eyal Gura, Co-founder of Healing October 7 Initiative: "We are happy to share this vision and collaborate with the Optimi team to bring this important group treatment protocol to the next proofing stage."
• Dane Stevens, CEO of Optimi Health: "This collaboration is a meaningful step forward for Optimi's MMDA drug product... To be selected as the supplier for a trial of this importance is an honour. We remain focused on supporting partners like MAPS Israel with high-quality GMP medicines that meet the standards of modern clinical research."