A new chapter in the search for effective treatments for depression is underway in Vancouver.
Numinus Wellness Inc. (TSX: NUMI) announced on Tuesday that its subsidiary, Cedar Clinical Research, has begun studying a potential new therapy for treatment-resistant depression (TRD) using COMP360 psilocybin. As a result, shares of NUMI jumped more than 30% to lately sell at 19 cents on the news as of the Phase 3 trial was released on Tuesday morning.
The study is part of the largest-ever international clinical investigation of psilocybin therapy, led by Compass Pathways. Paul Thielking, Chief Science Officer at Numinus, and his team are currently accepting participants who meet specific eligibility criteria for the study, which will take place in Draper, Utah.
“Compass is helping to lead the way in psilocybin research and development for treatment-resistant depression,” Thielking said in a statement. “We are very proud of the work we are doing to elevate the industry and contribute to the growing body of research.”
The program, which aims to enroll over 800 participants, consists of two pivotal trials each with a long-term follow-up component. Topline data from the trials are expected to be released in the summers of 2024 and 2025.
This phase 3 program follows results of Compass Pathways’ phase 2b trial, which were published in the New England Journal of Medicine. The phase 2b trial aimed to evaluate the efficacy and safety of a single dose of COMP360 psilocybin, 25mg or 10mg, versus a 1mg dose, in patients with TRD.
The results revealed that after a single 25mg dose of COMP360 psilocybin, combined with psychological support, 29.1% of the TRD patients were in remission by the third week.
Chief Medical Officer at Compass Pathways, Guy Goodwin, highlighted the significance of this work, pointing out that “tens of millions of people around the world suffer with depression that doesn’t respond to traditional treatments.”
He added that the results from the phase 2b study of the investigational COMP360 psilocybin therapy were very promising, and expressed hope that the data from the phase 3 program will form the foundation for submissions 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,” Goodwin said.