Numinus MAPS-Sponsored PTSD Trial Moves to Next Phase

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Mental healthcare company Numinus Wellness Inc. (TSX: NUMI) (OTC:NUMIF) is focused on helping people heal through the development and delivery of innovative treatments and safe, evidence-based psychedelic-assisted therapies

On March 30, Numinus Wellness announced that it has moved into the next phase of implementation of 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 hosted by MAPS Public Benefit Corporation (MAPS PBC), by recruiting and dosing the first clinical trial volunteer in Canada.

MAPPUSX is an extension of MAPS’ parent MAPP1 study, which investigated the safety of MDMA-assisted therapy for the treatment of severe PTSD. The trial is open to MAPP1 participants who were enrolled in the placebo arm or who were unable to receive treatment due to COVID restrictions.

Numinus hosts the Canadian locations of MAPPUSX, through two purpose-built clinics located in Montreal and Vancouver. The Montreal site began administering medication this week, under the direction of trial co-therapists Dr. Joe Flanders, VP Psychology, Numinus, and Dr. Emma Hapke, Staff Psychiatrist, University Health Network, and Principal Investigator of 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 end in mid-summer 2022.

“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. Today’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,” said Payton Nyquvest, Founder and CEO, Numinus.

Numinus Bioscience Receives Additional Approvals

Numinus Wellness Inc. (TSX: NUMI) (OTC:NUMIF) announced on March 14 that its licensed, state-of-the-art research facility, Numinus Bioscience has been approved for a Containment Level 2 (CL2) Pathogens and Toxins License by the Public Health Agency of Canada, following the facility upgrade. The new biosecurity license will bring new data to natural psychedelics, presenting additional intellectual property opportunities and another revenue generator through contract research services.

The license is in addition to Health Canada’s existing Numinus Bioscience controlled drug and substance dealer license. It highlights Numinus‘ long-term strategy to establish a center of excellence for research into natural psychedelics, including significant license changes and investments in advanced technologies like the Orbitrap, which identifies metabolites in the body and will play a key role in pharmacokinetic and preclinical studies.

Earlier in March, Numinus received approval from Health Canada to study Ayahuasca and San Pedro at its Numinus Bioscience research center. This license expansion further positions Numinus Wellness as a recognized global research centre for natural psychedelic medicines, and supplements the current work the company is undertaking on Psilocybe species and inherent synergistic compounds.

Botanical materials are notable for their role as blends with Ayahuasca, a psychoactive brew made from several plant materials and consumed in traditional Amazonian indigenous practices for ceremonial, medicinal, and spiritual purposes. Research will be conducted to develop standardized analytical methods for raw materials, finished Ayahuasca infusions and San Pedro (which contains the psychedelic compound, mescaline).

SOURCE Numinus Wellness Inc. (TSX: NUMI) (OTC:NUMIF)