Published on
December 8, 2022

Numinus Submits Clinical Trial Application to Health Canada for Experiential Psilocybin-Assisted Therapy Training Research

  • New clinical trial will provide experiential training to therapists learning to conduct psilocybin-assisted therapy.

  • Clinical trial dosing will use Numinus Bioscience's Psilocybin Tea, EnfiniTea – one of the first Phase 1 clinical trials that will report on whole Psilocybe mushroom safety.

VANCOUVER, BC, Dec. 8, 2022 /CNW/ - 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 its research division has submitted a clinical trial application to Health Canada to begin a new experiential training study that will enable practitioners training to provide Psilocybin-Assisted Therapy (PAT) the ability to experience and observe psilocybin sessions to further their understanding and PAT education.  Additionally, the clinical trial will use Numinus Bioscience's EnfiniTea, a whole mushroom Psilocybe tea product, for trial dosing. This is one of the first clinical trials globally that will be conducted with whole Psilocybe mushrooms, to assess their safety.

"We're proud to offer one of the first training programs with the option to participate in an experiential clinical trial for practitioners looking to expand their psychedelic-assisted therapy education," said Paul Thielking, Chief Science Officer, Numinus. "As these important therapies continue to develop and gain support, we foresee the psychedelic sector may experience a shortage in sufficiently trained PAT therapists.  We're honored to offer this unique experiential clinical trial opportunity alongside our well-regarded psychedelic training programs to expand the number of highly qualified practitioners and drive further access to those in need of these mental health treatments."

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. Numinus expects the clinical trial may be expanded to include additional Numinus clinic locations in the future.

"We expect the EnfiniTea Psilocybe tea we've developed will support expanded access to important psychedelic-assisted therapies, as it's uniquely shelf stable, consistently dosed and economical to produce," said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus Bioscience. "We're pleased to be able to utilize this product in the NUMT2 clinical trial, as research on whole Psilocybe  mushroom in a clinical setting  is limited in Canada and the results of this trial may support regulators in expanding access to whole-mushroom psychedelic-assisted therapies through Canada's Special Access Programme and other expanded access frameworks."

The NUMT2 clinical trial protocol will enable each practitioner volunteering for the trial to participate in both experiential and observational roles, receiving psilocybin-assisted therapy, as well as observing another participant receiving the therapy under the supervision and guidance of an experienced and trained therapy provider. Numinus intends to initially draw on volunteers for the clinical trial through those who have expressed interest through the Company's practitioner training program.  The clinical trial will also be open to other practitioners interested in volunteering to expand their knowledge of PAT therapy practices.

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

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Forward-looking statements

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. There is no assurance that Health Canada will approve the application. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.