Numinus’ Clinical Site Joins Compass’ Phase 3 Program On Psilocybin Therapy For TRD
Numinus Wellness Inc.’s NUMIF wholly-owned contract research organization Cedar Clinical Research has commenced a new study on COMPASS Pathways’ CMPS psilocybin therapy for Treatment-Resistant Depression (TRD).
Based in Draper Utah, the trial is part of the largest-ever international clinical program assessing psilocybin therapy throughout two pivotal trials, enrolling over 800 participants total and including long-term follow-up.
COMPASS’ Phase 3 program studies the company’s proprietary synthetic psilocybin, COMP360, paired with psychological support, in people with a TRD diagnosis.
It builds from the Phase 2b trial’s results, published in the international peer-reviewed medical journal NEJM, showing a single 25mg dose of psilocybin together with psychological support helped 29.1% of participants with TRD to sustain remission of depression three weeks post-administration.
With enrollment for this Cedar-based study open -for those with a TRD diagnosis and meeting eligibility criteria,- topline data from the whole Phase 3 clinical program is expected in summer 2024 (first study) and mid-2025 (second study.)
COMP360 has received the FDA’s Breakthrough Therapy designation, as well as the U.K.’s Innovative Licensing and Access Pathway (ILAP) designation, for TRD.
Meanwhile, COMPASS is also running Phase 2 clinical trials assessing the compound for the treatment of PTSD and anorexia nervosa.
Numinus CSO, Dr. Paul Thielking, says COMPASS is “helping to lead the way” in psilocybin R&D for TRD, and that Numinus is thrilled to participate alongside “to elevate the industry and contribute to the growing body of research.”
Dr Guy Goodwin, CMO of COMPASS, said the company’s Phase 2b study results were “very encouraging” and that COMPASS hopes data from the upcoming Phase 3 program, “a significant milestone” in the journey to make COMP360 available to patients and “towards building a better future for mental health care,” will form the basis for submission to regulatory bodies.