COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today 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.

COMPASS Pathways’ Capital Markets Day featured the following speakers and topics:

Setting the Scene
George Goldsmith: Welcome and introduction to COMPASS
Kabir Nath: Introduction and agenda for the event
Charlie Nemeroff, MD, PhD, The University of Texas at Austin, Dell Medical School: New horizons in neuropsychiatry

TRD and COMPASS’ Phase 3 Program
John Rush, MD, Duke University School of Medicine: TRD patient profile review
Guy Goodwin, MD/Trevor Mill: Phase 3 program and pivotal trial design
Sidney Zisook, MD, University of California, San Diego: Perspective on the COMPASS Phase 3 development program

COMP360 Psilocybin Therapy Delivery and Commercialization
Ekaterina Malievskaia, MD & Greg Ryslik: Clinical care innovation and digital tools
Marco Mohwinckel & Steve Levine, MD: Patient/market access and commercial model
Phyllis Foxworth, Depression and Bipolar Support Alliance: Patient perspective on living with TRD and psilocybin therapy

Beyond TRD
Guy Goodwin, MD: COMPASS’ Phase 2 study in PTSD and IIS review
Walter Kaye, MD, University of California, San Diego: Unmet need and current treatment paradigm in Anorexia Nervosa
Guy Goodwin, MD: COMPASS’ Phase 2 study in Anorexia Nervosa

Closing Remarks
Kabir Nath: Closing remarks

The virtual event was held on October 12 at 8:00 am ET (1 pm UK). The webcast replay is available here.

About COMPASS Pathways

COMPASS Pathways plc. is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running phase II clinical trials of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing.