A study has been launched that is investigating COMP360 psilocybin therapy – an investigational new therapy – for treatment-resistant depression (TRD).
Numinus Wellness has confirmed that its wholly-owned subsidiary, Cedar Clinical Research (CCR), has begun the study which is part of COMPASS Pathways’ Phase 3 programme in TRD.
The international study, based in Draper, Utah, is composed of two pivotal trials, each with a long-term follow-up component. It will enrol over 800 participants, with topline data expected in summer 2024 and mid-2025.
The launch of the Phase 3 programme follows positive results from COMPASS Pathways’ Phase 2b trial, published in the New England Journal of Medicine.
The objective of the randomised, 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.
Results showed that, after a single 25mg dose of COMP360 psilocybin, in combination with psychological support, 29.1% of participants with TRD were in remission by week three.
Dr. Paul Thielking, Chief Science Officer at Numinus, stated: “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.”
Thielking and the team have now begun accepting people with TRD who fulfil certain eligibility criteria to join the Phase 3 study.
Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, added: “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 programme will form the basis for our submission to regulatory bodies.
“We’re grateful to all the people involved in our Phase 3 programme 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.”
