Numinus Wellness Inc. (TSX:NUMI, OTC:LKYSF) said its wholly-owned subsidiary 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.
The study in Draper, Utah, forms part of Compass Pathways (NASDAQ:CMPS)'s phase 3 program in TRD. The international program comprises two pivotal trials, each with a long-term follow-up component, enrolling over 800 participants, with top-line data expected in summer 2024 and mid-2025.
The phase 3 program follows positive results from Compass Pathways (NASDAQ:CMPS)' phase 2 trial, published in the New England Journal of Medicine, the world's leading peer-reviewed medical journal.
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.
"COMPASS is helping to lead the way in psilocybin research and development for treatment-resistant depression," Dr. Paul Thielking, Chief Science Officer at Numinus, said in a statement.
"We are very proud of the work we are doing alongside COMPASS to elevate the industry and contribute to the growing body of research."
COMPASS is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health.
"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,” Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said.
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.
Contact the author at jon.hopkins@proactiveinvestors.com