COMPASS Pathways Announces Phase 3 of Pivotal Program Design

LONDON, Oct. 12, 2022 (GLOBE NEWSWIRE) — COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health , announced the pivotal Phase 3 program design for Psilocybin Therapy COMP360 in Treatment Resistant Depression (TRD) today during a virtual Capital Markets Day. The session, which was 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 access /market and business model, and a broader development pipeline (recording available here).

COMPASS’s program will be the world’s first-ever Phase 3 psilocybin therapy program, 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 comprised of three clinical trials, two pivotal trials and long-term follow-up, and is expected to begin by the end of 2022. The design of the pivotal program is as follows:

  • Pivotal trial 1 (COMP 005) (n=378): single dose monotherapy (25 mg) versus 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): Fixed repeat dose monotherapy using three dose arms: 25 mg, 10 mg and 1 mg. This trial is designed to determine if a second dose can increase the number of responders and/or improve the response observed in the company’s Phase 2b study and explore the potential for a significant treatment response after repeated administration of COMP360 10mg.
  • The primary endpoint of both pivotal trials is the change from baseline in the MADRS total score at week 6.

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

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

Phase 3 program of TRD and COMPASS
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 Delivery and Marketing of Psilocybin Therapy
Ekaterina Malievskaia, MD & Greg Ryslik: innovation in clinical care and digital tools
Marco Mohwinckel & Steve Levine, MD: Patient/market access and business model
Phyllis Foxworth, Depression and Bipolar Support Alliance: Patient Perspectives on Living with TRD and Psilocybin Therapy

Beyond TRD
Guy Goodwin, MD: COMPASS Phase 2 Study of PTSD and IBS Review
Walter Kaye, MD, University of California, San Diego: Unmet Need and Current Treatment Paradigm for Anorexia Nervosa
Guy Goodwin, MD: COMPASS Phase 2 Study in Anorexia Nervosa

Last word
Kabir Nath: Closing speech

The virtual event took place on October 12 at 8:00 a.m. ET (1:00 p.m. UK). The replay of the webcast is available here.

About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our goal is to improve the lives of those who suffer from mental health problems 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 Breakthrough Therapy by the U.S. 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 in Europe and North America. . This was the largest randomized, controlled, double-blind clinical trial of psilocybin therapy ever conducted, and our primary data showed a statistically significant (p

Availability of other COMPASS Pathways information
Investors and others should note that we communicate with our investors and the public through our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com) and on social media (LinkedIn) , including but not limited to investor presentations and investor information sheets, filings with the United States Securities and Exchange Commission, press releases, public conference calls and webcasts. The information we post on these channels and websites could be considered material information. Accordingly, we encourage investors, the media and others interested in us to regularly review the information posted on these channels, including the Investor Relations website. This list of channels may be updated from time to time on our Investor Relations website and may include additional social media channels. The content of our website or these channels, or any other website accessible from our website or these channels, should not be taken as incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some instances, forward-looking statements may be identified by words such as “may”, “could”, “will”, “could”, “should”, “should”, “expect”, “anticipate”, “believes”, “estimates”, “potential”, “continues” and “in progress”, or the negative form of these terms or other comparable terms, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements regarding, among other things, COMPASS’s strategic plans or objectives, COMPASS’s plans and anticipated timeline for its Phase III program in treatment-resistant depression and the possibility that this trial or other trials support regulatory filings and approvals, future accessibility of COMP360 Psilocybin Therapy, COMPASS’s ability to successfully launch and commercialize COMP360 Psilocybin Therapy, potential revenue streams if the therapy at psilocybin COMP360 is approved and the ability of COMPASS to advance psilocybin COMP360 therapy in other areas of unmet mental health needs and to discover and advance new drug compounds. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond within the control of COMPASS and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, among others: preclinical research and clinical development are long and uncertain, and therefore our preclinical studies and clinical trials may be delayed or interrupted, or may never advance to or into the clinic; and the risks and uncertainties described under “Risk Factors” in COMPASS’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q and other reports we have filed with US Securities. and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release as a result of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Requests
Media: Amy Lawrence, [email protected]+44 7813 777 919
Investors: Stephen Schultz, [email protected], +1 401 290 7324

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