VANCOUVER, BC, March 8, 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 novel therapies, congratulates Mind Medicine ("MindMed" NASDAQ: MNMD, Cboe Canada: MMED) on the positive data generated from its Phase 2b clinical trial of MM120 (lysergide d-tartrate) for the treatment of generalized anxiety disorder ("GAD"). The study showed that four weeks after a single 100-microgram dose of MM120, 48 percent of the participants achieved remission and no longer showed clinically significant anxiety, and 65 percent showed clinically meaningful improvement. Based on initial clinical data from the Phase 2b trial and the significant unmet medical need in treating GAD, the U.S. Food & Drug Administration ("FDA") has designated MM120 for GAD as a breakthrough therapy. 1
The research was conducted over 20 clinical trial sites with 198 participants. Numinus' Cedar Clinical Research Draper Utah research clinic was among the highest enrolling sites for the study, with its clinic at Murray, Utah, also participating. Dr. Reid Robison, Numinus' Chief Clinical Officer and Dr. Paul Thielking, Chief Science Officer, were Principal Investigators.
"We were pleased to participate in this trial of MM120, with the results indicating a robust and durable improvement for trial participants with GAD. This is an important development in treating a condition that is considered the second most common mental health condition among American adults," said Dr. Robison. "I particularly commend MindMed for designing a study that removed variables such as additional medications and psychotherapy so the effects of MM120 were isolated and fully evaluated."
"Our experience in operating clinical trials for leading drug developers, along with our collaborative approach, was a factor in our success as top enrolling sites for MindMed," added Payton Nyquvest, Numinus Founder and CEO. "We look forward to continuing to work with MindMed as it advances its important research into MM120. With more novel drug treatments moving through the clinical trial stages with the goal of being approved, Numinus is well-positioned with an infrastructure that includes clinical research, treatment clinics and practitioner training."
About Numinus
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 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
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 challenges and uncertainties inherent in product and/or treatment development and in the psychedelics industry generally, availably of suitable subjects, the uncertainties of clinical success, the possibility of adverse events, and the timeline for the availability of the treatment under investigation; the laws, challenges and risks involved in the production of a psychedelics drug; and the uncertainty of the level of demand, uptake and/or insurance coverage for treatment other risks that are set forth in 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.
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