Cedar Clinical Research selected as clinical research site for Cybin's Phase 3 Study of CYB003

VANCOUVER, BC, April 17, 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,  is proud to announce that its research site, Cedar Clinical Research ("CCR"), has been chosen as one of multiple sites for Cybin's Phase 3 pivotal, multinational clinical trial of CYB003 for the adjunctive treatment of Major Depressive Disorder ("MDD").

In its recently completed Phase 2 trial in participants with moderate to severe major depressive disorder, Cybin reported that at four months after dosing, 75% of patients receiving two 16mg doses of CYB003 achieved remission from depression symptoms. With the Phase 2 trial data, the U.S. Food and Drug Administration ("FDA") granted CYB003 breakthrough therapy designation, potentially shortening the drug development timeline.

The Phase 3 trial for CYB003 is planned to commence enrollment mid-2024 and focus on its safety and efficacy. CCR's Murray, Utah, location will be one of the 15 U.S. sites. Dr. Paul Thielking, Chief Science Officer of Numinus, will be the Principal Investigator.

"The Phase 2 results from the CYB003 trials were impressive and demonstrated the potential for treating a serious condition that affects over 20 million Americans," said Dr. Thielking. "We look forward to working with Cybin on the Phase 3 trials to add to the knowledge of CYB003's efficacy and address an important unmet need in patient care."

"With many drug candidates advancing to later stages of clinical trials, 2024 is turning out to be a critical year for psychedelic-assisted therapy," added Payton Nyquvest, Numinus Founder and CEO. "We are proud of our role in working with drug developers to facilitate the important research that will help move these candidates to FDA approval and, ultimately, patient care."

To learn more about enrolling in the CYB003 Phase 3 Trial, please visit this link.

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, and Instagram.

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SOURCE Numinus Wellness Inc.