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.
