Numinus Completes First MDMA Administration in PTSD Trial Sponsored by MAPS

Update marks the first MDMA-assisted therapy session at a Numinus clinic

Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that it has advanced to the next implementation phase in the clinical trial "A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)" sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC), by enrolling and dosing the first clinical trial volunteer in Canada .

Numinus hosts the Canadian sites for MAPPUSX, through two purpose-designed clinics located in Montreal and Vancouver . This week, the Montreal site began drug administration, led by trial co-therapists Dr. Joe Flanders , VP Psychology, Numinus, and Dr. Emma Hapke , Staff Psychiatrist, University Health Network and Principal Investigator for the MAPS-sponsored trial. The treatment follows MAPS' protocol of three sessions of MDMA administration and therapy, each to be followed by three integration sessions. The full program is expected to complete in mid-summer 2022.

"Numinus is excited to administer the first MDMA-assisted therapy dosing of MDMA at our clinics and contribute to the growing body of MAPS' research," says Dr. Flanders. "Designed with accessibility and ethics at its core, we look forward to the continuation of this study and translating the findings into clinical practice."

MAPPUSX is an extension of MAPS' Phase 3 studies to investigate the safety and efficacy of MDMA-assisted therapy for treating severe PTSD. The MAPPUSX trial is open to those participants from the Phase 3 studies who received the placebo drug and therapy and those who could not receive treatment due to COVID restrictions. The resulting safety data will be provided to regulatory bodies in the sponsor's New Drug Application.

"We are proud of our clinical and research teams who have been and continue to be instrumental in driving MDMA-assisted therapy for PTSD research forward in Canada ," said Payton Nyquvest , CEO and founder, Numinus. "This week's trial progress is another step in our strengthening collaboration with MAPS as we work together to make psychedelic-assisted therapy accessible to those in need. We will continue to work with MAPS, Health Canada and the industry to help make MDMA-assisted therapy a reality."

Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at numinus.com and follow us on LinkedIn , Facebook , Twitter , and Instagram .

Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator . Learn more at maps.org

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SOURCE Numinus Wellness Inc.

View original content: https://www.newswire.ca/en/releases/archive/March2022/30/c2988.html