- Numinus has submitted a Clinical Trial Application (CTA) to Health Canada to enable MDMA-assisted therapy Experiential Opportunities for practitioners as part of an investigational Phase 1 clinical trial.
- If approved, Numinus intends to make the Experiential Opportunity available to practitioners as part of its psychedelic-assisted therapy education and training program.
- If the CTA is approved, MAPS will provide Numinus with permission to use its protocol as part of this Experiential Opportunity, the first such permission granted by MAPS.
VANCOUVER, BC, June 15, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus"), (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and evidence-based investigational psychedelic-assisted therapies, announced a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS), to support psychedelic experiential opportunities for practitioners as part of a clinical study. If the Clinical Trial Application (CTA) submitted to Health Canada is approved, the MDMA-assisted therapy experiential opportunity would be available only through Numinus.
The CTA has been submitted by Numinus through its wholly-owned subsidiary Numinus Wellness Research Inc. If approved by Health Canada, the clinical trial would enable practitioners interested in MDMA-assisted therapy the ability to experience and observe MDMA sessions to further their understanding of psychedelic-assisted therapy. The Numinus-sponsored clinical trial would use clinical MDMA produced by Optimi, a Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply psychedelic substances for clinical trials.
"If the trial protocol is approved, Numinus would be best positioned to provide training with our experiential opportunities," said Payton Nyquvest, Founder and CEO . "Practitioners who complete our MDMA-assisted therapy education program, or have already completed previous MDMA-assisted therapy programs and are qualified to enroll in our Practical Applications course, would be able to apply to participate in the experiential clinical trial – enabling them to observe, deliver, and receive the therapeutic protocol as part of their training experience."
The clinical trial, formally titled A Phase 1, Open-Label, Single-Arm Study to Evaluate MDMA Experiential Training in Healthy Volunteers and Expand Knowledge and Qualifications of Therapists Planning to Conduct MDMA-Assisted Therapy (NUMT1), would initially be conducted at Numinus' clinics in Vancouver, if approved. The trial may be expanded to include additional Numinus clinic locations in the future.
Mr. Nyquvest continued: "With a shared vision and commitment to driving greater understanding and accessibility to MDMA-assisted therapies, we believe this new offering is a gateway to greater collaboration with MAPS in the months ahead."
Rick Doblin, Founder and President of MAPS added: "Our 37-year journey to medicalize the therapeutic use of psychedelics has never been closer to a reality, and we're thrilled to have Numinus as a partner in this work. Experiential training is an important element of a practitioner's training in many therapeutic modalities, and through this carefully controlled clinical trial, Numinus is supporting our shared goal of providing training to practitioners who may one day deliver psychedelic-assisted therapy to individuals who need it."
If approved by Health Canada, the NUMT1 clinical trial protocol would enable each trial participant to participate in both experiential and observational roles, receiving investigational MDMA-assisted therapy, as well as observing another participant receiving the therapy under the supervision and guidance of an experienced and trained therapy provider. Numinus intends to draw on volunteers for the clinical trial through practitioners who have expressed interest through the Company's practitioner training program and those practitioners who have previously completed the MAPS protocol training and meet the qualifications to enroll in our MDMA-Practical Applications course.
Practitioners interested in learning more about the investigational MDMA-assisted therapy experiential training clinical trial can find more information at www.numinus.com/mapspartnership.
Numinus already provides several psychedelic-assisted therapy training courses for practitioners. For more information on training options, please see www.numinus.com/our-training-selection/.
MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
About Numinus
Numinus Wellness (TSX: NUMI) 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 www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
Forward-looking statements
Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including approval of MDMA-assisted therapy for any indication or at all; restrictions that may be placed on use of MDMA by regulatory authorities; safety and efficacy of MDMA-assisted therapy; acceptance, uptake and commercialization of MDMA-assisted therapy; approval of the clinical trial by Health Canada or the FDA, as applicable; availability of suitable subjects for the trial; the effect, if any, of having obtained certification on any particular trainee or such trainee's business or profile; and other risks that are set forth in our annual information form dated December 12, 2022 and available on SEDAR at www.sedar.com. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
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SOURCE Numinus Wellness Inc.
