Numinus announces milestones in compassionate access trial for MDMA-assisted therapy in collaboration with MAPS Public Benefit Corporation
Trial enters pre-implementation stage having met several key milestones towards expanding access to patients with PTSD
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, is pleased to share that the single-arm, open-label, compassionate access 1 trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPS Public Benefit Corporation (MAPS PBC) a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) the leading developer of the treatment protocols, research, and MDMA-assisted therapy training programs.
“We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate,” said Payton Nyquvest , CEO of Numinus. “At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with the Multidisciplinary Association of Psychedelics for Studies (MAPS PBC) and will work together to provide those experiencing PTSD with more treatment options.”
This first-of-its-kind trial in Canada has advanced and successfully transitioned into the pre-implementation stage at Numinus‘ Vancouver clinic. This follows the successful completion of several milestones, starting with the recruitment of therapists, physicians, and staff in preparation for participant enrolment and the ultimate analysis of therapy outcomes. The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options.
In November 2020 , eight Numinus therapists graduated from Part B of the MAPS MDMA therapist training program. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.
A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trial’s implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID-19 public health protocols.
“Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD,” said Amy Emerson , CEO of MAPS PBC.
Numinus is also pleased to announce that its Medical and Therapeutic Services Director, Dr. Devon Christie , will serve as both the trial’s Principal Investigator and as a therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management, is a certified Relational Somatic Therapist, and is already MAPS-trained in the delivery of the MAPS MDMA-assisted therapy for PTSD.
“I am thrilled to be involved in a long-awaited clinical program that will help pave the way towards wider use of MDMA-assisted psychotherapy for those experiencing PTSD,” said Dr. Christie. “The key milestones announced today are a true testament to our teams’ commitment to establishing the physical, technical, clinical, and human resource infrastructure needed to swiftly move through the trial’s formal implementation stages and ultimately towards the recruitment of the first participant.”
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 .
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal .
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
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.
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
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
SOURCE Numinus Wellness Inc.
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