Numinus Receives Clinical Trial Application Approval from Health Canada for Experiential Psychedelic-Assisted Therapy Training using Psilocybe Cubensis Tea

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Feb 01, 2023, 07:00 ET

Clinical trial will be the first to test whole Psilocybe mushrooms for safety and efficacy in a clinical setting; study is expected to provide important data to support increased access to psilocybin-assisted therapy.
Clinical trial will provide experiential training to therapists learning to conduct psilocybin-assisted therapy and will use Numinus Bioscience's Psilocybin Tea, EnfiniTea, for dosing.

VANCOUVER, BC, Feb. 1, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that it has received approval from Health Canada for its experiential training study that will test the safety and clinical efficacy of whole Psilocybe cubensis tea for therapeutic use, and enable practitioners to further their understanding of psychedelic-assisted therapy through experiential training.

EnfiniTea tea bags by Numinus Bioscience (CNW Group/Numinus Wellness Inc.)

"We're thrilled that Health Canada has provided us with their prompt approval and support in starting this important clinical trial," said Payton Nyquvest, CEO and Founder, Numinus. "As the first clinical trial to study the safety and clinical efficacy of whole psilocybe mushrooms in their naturalistic form, we expect this data will be instrumental in providing health regulators with the information they need in order to make decisions around expanding access to psilocybin-assisted therapies using Psilocybe mushrooms."

"We're honored to offer this unique experiential clinical trial opportunity alongside our well-regarded psychedelic-assisted therapy training programs," said Paul Thielking, Chief Science Officer, Numinus. "We recognize that one of the challenges of the psychedelic-therapy industry is having enough properly trained administers of the therapy. By offering experiential training opportunities for practitioners interested in providing psilocybin-assisted therapies, Numinus will help ensure that enough sufficiently trained therapists are available to deliver these important mental health treatments in the future."

The clinical trial, formally titled A Phase 1, Open-Label, Single-Arm Study to Evaluate Psilocybin Experiential Training in Healthy Volunteers and Expand Knowledge and Qualifications of Therapists Planning to Conduct Psilocybin-Assisted Therapy (NUMT2), will initially be conducted at Numinus' clinic in Vancouver, and will begin selecting volunteers in the next several weeks. Study subjects will be selected from practitioners who have trained or are currently training to provide psilocybin-assisted therapy through Numinus' Practitioner Training Program or other approved training programs. Initial results from the study are expected to be published in the second half of 2023.

The protocol for the clinical trial will include three sessions per study participant: one preparatory session, one dosing session, and one integration session, which will be followed by an observation period and participant interviews and questionnaires. Over the course of the clinical trial, each experiential training study volunteer will participate both as a study participant receiving the protocol and as an observer for another participant's sessions (overseen by an experienced practitioner).

The clinical trial will use Numinus Bioscience's EnfiniTea, a whole mushroom Psilocybe tea product delivering 25mg of psilocybin to patients when administered as directed, for trial dosing. EnfiniTea is produced using Numinus' own validated strain of Psilocybe cubensis BP-Star, and is uniquely shelf stable, consistently dosed and economical to produce. The product has also been submitted to Health Canada to be included on the psilocybin supplier list for the federal Special Access Program, through which health care providers can apply to provide psilocybin-assisted therapy, among other psychedelic-assisted therapies, to patients with demonstrable need.

Companies interested in learning more about EnfiniTea for clinical trial use are invited to email [email protected] for more information.

Practitioners interested in learning more about Numinus' training programs are encouraged to visit www.numinus.com/services/practitioner-training or email [email protected] for more information.

About Numinus

Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements

Forward-looking statements in this news release include, but are not limited to, the potential effects of Psilocybe cubensis tea, EnfiniTea and other psychedelic treatments, the potential use in treating mental health conditions and the timing, completion and results of the experiential training study. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede the Company's future business plans; the results of continued development, marketing and sales; and other factors beyond the control of the Company. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

The Company makes no medical, treatment or health benefit claims about Psilocybe cubensis tea, EnfiniTea, other psychedelic treatments. The efficacy of psilocybin, psilocybin analogues, Psilocybe cubensis tea, EnfiniTea or other psychedelic compounds or nutraceutical products remains the subject of ongoing research. There is no assurance that the use of psilocybin, psilocybin analogues, Psilocybe cubensis tea, EnfiniTea or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials.

SOURCE Numinus Wellness Inc.