First-of-its-kind trial in
Canada will pave the way for
expanded MDMA-assisted treatment to support patients with
posttraumatic stress disorder
VANCOUVER, BC, Dec. 2, 2020 /CNW/ - Numinus Wellness
Inc. ("Numinus" or the "Company") (TSXV: NUMI), a company
creating an ecosystem of health solutions centered around
developing and supporting the safe, evidence-based, accessible use
of psychedelic-assisted psychotherapies, and the Multidisciplinary
Association for Psychedelic Studies Public Benefit Corporation
(MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary
Association for Psychedelic Studies (MAPS), are pleased to announce
a collaboration agreement that will seek approval to deliver
MDMA-assisted psychotherapy for posttraumatic stress disorder
(PTSD) through a single-arm, open-label, compassionate
access1 trial. This clinical trial will be the
first-of-its-kind in Canada and
will take a meaningful step in furthering the accessibility of
MDMA-assisted treatment options for those experiencing PTSD around
the world.
Through the completion of six Phase 2 trials and ongoing Phase 3
trials, MAPS and MAPS PBC have undertaken ground-breaking research
demonstrating that MDMA-assisted psychotherapy — which recently
received "breakthrough therapy" status from the U.S. Food and Drug
Administration (FDA) — may provide sufficient benefit to patients
experiencing PTSD to support approval from the FDA.
This compassionate access trial, if approved, will be conducted
at Numinus' Vancouver clinic,
providing MDMA-assisted psychotherapy to an initial 20 individuals
experiencing PTSD and collecting outcome and safety data for Health
Canada. Numinus' physicians, therapists and staff will be trained
to deliver the treatment under MAPS' clinically-tested PTSD
treatment protocol prior to approval by Health Canada.
"I am delighted to announce this collaboration agreement which,
leveraging MAPS' evidence-based treatment protocol and Numinus'
clinical infrastructure, will open the door to MDMA-assisted
psychotherapy in Canada," said Dr.
Devon Christie, Medical Director at
Numinus and a MAPS-trained therapist for the delivery of
MDMA-assisted psychotherapy.
"Training Numinus therapists in the MDMA-assisted psychotherapy
protocol for PTSD will provide a meaningful expansion of access to
the ongoing research program for this promising treatment," said
Amy Emerson, CEO of MAPS PBC.
"Though this treatment is still investigational, if approval is
granted through the regulatory pathway this collaboration will
bolster our shared goal of addressing the enormous — and growing —
need for improved proven treatments for people suffering from
PTSD."
Dr. Rick Doblin, Founder and
Executive Director of MAPS, adds, "Our commitment to open science
is rooted in our mission to develop the cadre of qualified
practitioners who will provide this world-class therapy. We're
excited to work with Numinus to build the case for regulatory
approval through this compassionate access trial and expand best
practice clinical infrastructure."
"We are thrilled to collaborate with MAPS and deliver the
meaningful framework that they have spent decades building to
better support those experiencing PTSD," said Payton Nyquvest, CEO of Numinus. "At Numinus,
our mandate is to explore and expand patient access to
psychedelic-assisted psychotherapies. We are proud to work
alongside MAPS in furthering the regulatory landscape for
psychedelic-assisted therapies, including MDMA, and setting the
stage for the healthcare system of tomorrow."
NOTE
The safety and efficacy of MDMA-assisted psychotherapy is
currently under investigation. It has not yet been approved by
Health Canada or the FDA, does not work for everyone, and carries
risks even in therapeutic settings. These statements are no
guarantee of future Health Canada or FDA approval or availability
of MDMA-assisted psychotherapy. These statements necessarily
involve known and unknown risks and uncertainties, which may cause
actual outcomes to differ materially from projections.
1 Health Canada
recommends compassionate access open-label clinical trials when
drug manufacturers anticipate exceptional demand for a drug, "to
meet the needs of patients not eligible for enrollment in other
pivotal trials" (Special Access Program for Drugs: Guidance
document for industry and practitioners, Published 2020-10-14).
This program is not related to the U.S. FDA Expanded
Access program, sometimes referred to as "compassionate use"
or the Breakthrough Therapy designation.
ON BEHALF OF THE BOARD OF NUMINUS WELLNESS INC.
Payton Nyquvest
President, Chief Executive Officer and Chair
About Numinus
Numinus Wellness Inc. (TSXV: NUMI) is a
mental health and wellness company creating an ecosystem of
solutions centred around safe, evidence-based, accessible
psychedelic-assisted psychotherapy to help people heal and be
well.
Numinus Health is dedicated to delivering innovative
treatments to address physical, mental, and emotional health,
through clinics and virtual services.
Numinus R&D is conducting implementation science
and leveraging partnerships to beta-test and refine optimal models
of psychedelic-assisted psychotherapy delivery, setting the stage
for approved routine use in mental health and wellness care.
Numinus Bioscience is focused on developing testing
methods and effective formulas for the evolving psychedelics space.
Health Canada licences, scientific
expertise, and new technologies facilitate ongoing innovation, and
high-throughput contract services generate established revenue.
Learn more at numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
ABOUT MAPS
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. Since its founding,
MAPS has raised over $100 million for
psychedelic therapy and medical marijuana research and
education.
www.maps.org
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS
Public Benefit Corporation (MAPS PBC) catalyzes healing and
well-being through psychedelic drug development, therapist training
programs, and sales of prescription psychedelics while prioritizing
public benefit above profit. Founded in 2014, MAPS PBC is a wholly
owned subsidiary of the Multidisciplinary Association for
Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization
www.mapspublicbenefit.org
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SOURCE Numinus Wellness Inc.