Open-label clinical trial will evaluate and refine best practices for the delivery of psilocybin-assisted psychotherapy for participants with tobacco, stimulant, alcohol, and/or opioid disorders

 Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI ), a company creating an ecosystem of solutions centred on the research, development, and delivery of safe, evidence-based, accessible psychedelic-assisted psychotherapies, has announced it will undertake a compassionate access clinical trial of psilocybin-assisted psychotherapy for substance use disorders. This study will enable the company to implement, test, and refine optimal protocols for the use of psilocybin-assisted psychotherapy for participants with a range of substance use disorders and will be conducted in collaboration with Syreon Corporation a global contract research organization with expertise in conducting clinical trials across a broad range of chronic and complex diseases. The study will involve an initial 30 participants who will take part in a motivational enhancement psychedelic psychotherapy intervention with psilocybin.


According to Health Canada’s Special Access Programme , compassionate access single-arm open-label clinical trials can be incorporated into drug development planning to “meet the needs of patients who are not eligible for enrollment in other pivotal trials” and is one of Health Canada’s preferred means for patients to access drugs that are not yet available on the market.

“Research has already demonstrated great promise for psilocybin-assisted psychotherapy as a treatment for certain substance use disorders,” said Chief Medical Officer, Dr. Evan Wood . “But, psilocybin is still illegal in Canada . This compassionate access trial will begin to address the hurdle of public accessibility, while allowing us to evaluate service delivery models and study the impacts of psilocybin-assisted psychotherapy as an adjunct to standard of care treatments for substance use disorders.”

The study builds upon a growing body of research demonstrating psilocybin-assisted psychotherapy’s efficacy as a novel treatment for specific substance use disorders. A pilot study focusing on tobacco addiction at Johns Hopkins University found that 12 months after psilocybin therapy sessions, approximately 70 percent of participants remained completely abstinent from smoking and approximately 90 percent rated their psilocybin experience as among the most personally meaningful experiences of their lives. A study of psilocybin-assisted psychotherapy for alcohol use disorder at New York University has also demonstrated major reductions in alcohol use.

The evolving international regulatory landscape has opened the door to accessibility of psilocybin-assisted psychotherapy, and Numinus‘s compassionate access trial is expected to contribute to continued interest in expanding access.

“The tides are turning for the regulated use of psilocybin, as witnessed earlier this month in the United States . A yes vote for Measure 109 in Oregon permits licensed service providers to provide psilocybin-assisted psychotherapy, and Health Canada has an ongoing provision of exemptions for psilocybin for medical use,” said Founder, CEO, and Chair, Payton Nyqvest . “By increasing access through a compassionate access trial, we hope to help lead the way to regulation in Canada through our implementation science approach which will provide critical outcome and safety data to health regulators.”

Numinus‘ compassionate access trial is the first in a series of planned projects and partnerships aimed at expanding access to MDMA for treatment of PTSD and psilocybin for treatment of substance use disorders. These implementation science initiatives will allow the company to refine clinical protocols and strategies for when these medications are approved for widespread use by regulating bodies.

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 Syreon
Syreon provides a full suite of adaptive clinical trials, health economics and outcomes research ensuring safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.

Syreon partners with an elite portfolio of global pharmaceutical corporations and early-stage biotech companies to speed the evaluation of new therapies and improve health outcomes. Its expert research services identify precise therapeutic needs, rapidly evaluate new health interventions, monitor clinical use and define optimal economic value in today’s competitive health environment.

Syreon scientists have contributed to many groundbreaking innovations, from the first blockbuster signal inhibitors, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, stem cell therapeutics and other recent initiatives in precision medicine.

Syreon’s head offices in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, providers, purchasers and payers. Our services through all phases of study planning, operation, analysis and reporting ensure safe, effective and value-driven clinical use.

www.syreon.com

Forward Looking Statements
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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