May 30, 2023

Numinus to research COMP360 psilocybin therapy in treatment-resistant depression as part of large phase 3 study

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The research conducted at Cedar Clinical Research in Draper is part of the first ever phase 3 program of psilocybin therapy, and the largest of its kind

VANCOUVER, BC, May 30, 2023 /CNW/ - Numinus Wellness Inc. (TSX: NUMI) is pleased to announce that Cedar Clinical Research (CCR) has begun studying COMP360 psilocybin therapy, an investigational new therapy for treatment-resistant depression (TRD), as part of the largest-ever international clinical study of psilocybin therapy. Dr. Paul Thielking, Chief Science Officer at Numinus, and the team have begun accepting people with TRD who fulfill certain eligibility criteria to join the study.

The study in Draper, Utah, is a part of COMPASS Pathway's phase 3 program in TRD. The international program is composed of two pivotal trials, each with a long-term follow-up component. It will enroll over 800 participants, with topline data expected in summer 2024 and mid-2025.

The launch of the phase 3 program follows positive results from COMPASS Pathways' phase 2b trial, published in the New England Journal of Medicine, the world's leading peer-reviewed medical journal. The objective of the randomized, controlled, double-blind phase 2b study was to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. After a single 25mg dose of COMP360 psilocybin, in combination with psychological support, 29.1% of participants with TRD were in remission by week 3.

"COMPASS is helping to lead the way in psilocybin research and development for treatment-resistant depression. We are very proud of the work we are doing alongside COMPASS to elevate the industry and contribute to the growing body of research."
~ Dr. Paul Thielking, Chief Science Officer at Numinus

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said:

"Tens of millions of people around the world suffer with depression that doesn't respond to traditional treatments. The results from our phase 2b study of investigational COMP360 psilocybin therapy were very encouraging, and we hope that the data from our pivotal phase 3 program will form the basis for our submission to regulatory bodies. We're grateful to all the people involved in our phase 3 program around the world. It is a significant milestone in our journey to make COMP360 psilocybin therapy available to patients, and towards building a better future for mental health care."

People who are interested in taking part in the study should go to https://compasspathfinderstudies.com/ or https://numinus.com/clinical-trials/psychedelics/#!/study/28 to understand if they might be eligible to join.

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 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.

Cedar Clinical Research (CCR) is a wholly-owned subsidiary of Numinus Wellness Inc.

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

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running phase 2 clinical trials of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Forward-looking statements

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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, possibility of adverse events, and the timeline for the availability of the treatment under investigation; the laws, challenges and risks involved in 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 (a) Numinus public disclosures available on SEDAR at www.sedar.com, and (b) COMPASS public disclosures available on EDGAR at www.sec.gov/edgar. Forward-looking statements are based on estimates and opinions of the company's respective management at the date the statements are made. Neither Compass nor Numinus undertake any obligation to update forward-looking statements even if circumstances or estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

View original content:https://www.prnewswire.com/news-releases/numinus-to-research-comp360-psilocybin-therapy-in-treatment-resistant-depression-as-part-of-large-phase-3-study-301836893.html

SOURCE Numinus Wellness Inc.

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