Numinus and MAPS Public Benefit Corporation announce collaboration agreement to seek approval of MDMA-assisted psychotherapy for PTSD single-arm, open-label trial

Quick Take:

Numinus Wellness Inc. (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.”

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

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.

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