Numinus Wellness Submits Clinical Trial Application

VANCOUVER, BC, March 20, 2024 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, announces that it has submitted a Clinical Trial Application to Health Canada to examine the feasibility of a group model in MDMA-assisted psychotherapy enrolling trainee practitioners as participants.

If approved, the trial would allow Numinus to study MDMA-assisted psychotherapy with groups and better understand the optimum number of therapists required to deliver the programs safely. It may also provide eligible trainees with the opportunity to build core competencies and legally experience MDMA.

"As research into MDMA's efficacy in addressing serious mental conditions is increasing, it is particularly important that practitioners advance their knowledge of optimum delivery in a clinical setting," said Payton Nyquvest, Numinus Founder and CEO. "Our goal in designing this study is to explore the feasibility of a group model and take steps to help establish best practices in group-based therapy for MDMA and contribute to the body of evidence of its safety."

"Considering the large potential patient population that could be seeking care should MDMA-assisted therapy receive approval, it will be essential for clinics and practitioners to gain the knowledge and experience to deliver this groundbreaking treatment for PTSD," added  Rick Doblin, PhD., an unpaid volunteer Numinus Strategic Advisor. "This study has the potential to significantly enhance patient outcomes by providing a means for practitioners to gain valuable insights."

The clinical trial is formally titled "Phase 1 Exploration of Feasibility and Optimal Therapist Numbers in Group Model MDM-Assisted Psychotherapy: A Study on Safety, Delivery, and Practitioner Training." If approved, it will be the first of its kind. Details on participating in the clinical trial will be posted on the Numinus website at https://numinus.com/en-ca/clinical-trials/.

Numinus Wellness Inc. (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 research, clinic care and practitioner training – 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.

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, including approval of MDMA-assisted therapy for any indication or at all; restrictions that may be placed on the use of MDMA by regulatory authorities; safety and efficacy of MDMA-assisted therapy; acceptance, uptake and commercialization of MDMA-assisted therapy; approval of the clinical trial by Health Canada or the FDA, as applicable; availability of suitable subjects for the trial; the effect, if any, of having obtained certification on any particular trainee or such trainee's business or profile; and other risks that are set forth in our annual information form dated November 29, 2023 and available on SEDAR at www.sedarplus.ca. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/numinus-wellness-submits-clinical-trial-application-302093956.html

SOURCE Numinus Wellness Inc.