COMPASS pathways announces phase 3 pivotal program design for COMP360 in treatment resistant depression

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COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today (October 12) announced the Phase 3 pivotal program design for COMP360 psilocybin therapy in treatment resistant depression (TRD) during a virtual Capital Markets Day. The session, attended by members of COMPASS Pathways’ executive leadership and key opinion leaders, included a review of the TRD treatment landscape as well as COMPASS’ clinical care and digital strategy, patient/market access and commercial model, and broader development pipeline (recording available here).

COMPASS’ program will be the first ever Phase 3 program of psilocybin therapy globally, and follows positive results from its Phase 2b study in treatment-resistant depression, presented at the American Psychiatric Association annual meeting in May 2022. The Phase 3 program is composed of three clinical trials, two pivotal trials and one long-term follow-up, and is expected to commence by the end of 2022. The pivotal program design is as follows:

  • Pivotal trial 1 (COMP 005) (n=378): a single dose (25mg) monotherapy compared with placebo. This trial is designed to replicate the treatment response seen in the Company’s Phase 2b study (n=233).
  • Pivotal trial 2 (COMP 006) (n= 568): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg. This trial is designed to investigate if a second dose can increase the number of responders and/or improve response seen in the Company’s Phase 2b study and explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg.
  • The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at Week 6.

Note, the second of these trials is due to report in mid-2025, so licensing is likely to take place later than this.

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