“Completing the first legal extraction of Psilocybe mushrooms in Canada is a critical next step to providing a natural product for safe, evidence-based psilocybin-assisted psychotherapies to those in need,” said Payton Nyquvest, CEO, Founder, and Chairman. “Numinus continues to be a vanguard of positive change for the industry, and this announcement demonstrates our ability to deliver yet another first.”
Numinus Bioscience is establishing itself at the forefront of analytical testing for psychedelic substances, as a centre of excellence for psychedelic product research and development, and as an ancillary for psychedelic therapy clinical trials. Health Canada licences, scientific expertise, and state-of-the-art technologies facilitate ongoing innovation, while revenue from high-throughput contract cannabis testing is reinvested to further its psychedelic initiatives.
“This is an important milestone in our comprehensive research strategy, following our successful harvest announced in October,” said Sharan Sidhu, Science Officer and General Manager. “In the extraction process, Numinus Bioscience’s goal is to optimize Psilocybe mushrooms to standardize psilocybin and multiple therapeutically important components, increasing the efficacy of the extract. To further our position as a centre of excellence in the space, we are in the process of submitting amendments to supply the extract for use in clinical trials and the Special Access Programme, which, when accepted, will mark a significant move forward in scaling the delivery of psychedelic-assisted therapies.”
“While direct comparisons cannot be made, there is a clear recognition in the cannabis space that synthetic cannabinoids are far less attractive than naturally occurring cannabinoids,” indicated Dr. Evan Wood, Numinus’ Chief Medical Officer. “Numinus is of the view that, ultimately, nature knows best, and we’re excited to be at the forefront of exploring the fascinating world of working with Psilocybe mushrooms as part of a focused drug development program.”
This announcement follows Numinus’ advocacy work that contributed to Health Canada’s groundbreaking announcement of its intention to revise the Special Access Programme (SAP) to permit access to MDMA and psilocybin-assisted psychotherapy in the same way other investigational medications are accessed in Canada. In addition, earlier this week Numimius announced the exciting acquisition of Montreal -based Mindspace Psychology Services Inc (DBA Mindspace Wellbeing) bringing together the capabilities of two leading Canadian organizations to develop and scale delivery of evidence-based psychedelic-assisted psychotherapy.
Health Canada’s Notice of Intent regarding the SAP will be open for public consultation and comments for the next 60 days, and Numinus strongly encourages the community to weigh in on the benefits of the revision. View the notice here: http://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb2.
To share comments and thoughts related to the SAP, please email [email protected]a.
About Psychedelic-Assisted Psychotherapy
Psychedelic-assisted psychotherapy has gained a great deal of interest within the medical community and general public as research results demonstrate its superior effectiveness for a range of mental health conditions. These results are contributing to a paradigm shift in both the understanding and treatment of mental health conditions.
Numinus has announced plans to embark upon open-label compassionate access clinical trials of psilocybin-assisted psychotherapy for substance use disorders and MDMA-assisted psychotherapy for PTSD, enabling it to implement, test and refine optimal protocols for delivery before these therapies are widely accessible. This includes developing physical and human resource infrastructure more broadly to deliver psychedelic-assisted psychotherapy including for Special Access Programme patients.
Numinus is uniquely positioned to provide patients with MDMA and psilocybin-assisted psychotherapy under the expanded SAP revision based on its international partnerships and extensive work completed on developing safe and evidence-based protocols for psychedelic-assisted psychotherapy. The Company is also a leader in the industry as the first public entity in Canada to receive a licence to produce and extract psilocybin from mushrooms, the first to complete a legal harvest of psilocybe mushrooms using this licence and the holder of a Health Canada dealer’s licence to import, export, possess, test and distribute MDMA, psilocybin and other psychedelics.
Applications for Numinus’s compassionate access trials and for access under the SAP, pending approval, are not yet open. To be advised of the status and procedures for applications when available, register for Numinus’s newsletter.
ON BEHALF OF THE BOARD OF NUMINUS WELLNESS INC.
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.
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.
For further information: Dana Harvey, Chief Communications Officer, [email protected]