- 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.