Business Wire

Compass Pathways Announces Publication of Results from COMP004 Study on COMP360 Psilocybin for Treatment-Resistant Depression

Share

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression (TRD). The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses.

The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks (p<0.001), with durable response for up to 12 weeks.

Key COMP004 findings

  • Durable improvement in symptoms observed. The analysis of all patients in COMP001 revealed a longer time to relapse for patients receiving 25 mg compared with 10mg and 1 mg, with the median time to a depressive event of 92 days for the 25 mg dose group, 83 days for the 10 mg and 62 days for the 1 mg group.
  • Extended benefit for a subgroup. A post hoc analysis revealed a substantial difference in time to depressive event for those who enrolled in COMP004 from COMP001 in the 25 mg group compared to the 10mg and 1mg groups, with median times of 189 days for the 25 mg group, 43 days for the 10 mg group, and 21 days for the 1 mg group.
  • Safety monitoring. COMP360 was generally well tolerated. Three participants reported experiencing a treatment emergent serious adverse event (TESAE) post-enrollment to COMP004, occurring more than 6 months after a single dose administration and all deemed unrelated to study drug.

These COMP004 study data were published in the March edition of the Journal of Clinical Psychiatry.

COMP360 is a synthetic form of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions when administered with psychological support.

“Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Dr. Guy Goodwin, Chief Medical Officer. “This study together with the Phase 2b (COMP001) suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.”

TRD is a condition in which individuals with major depressive disorder do not respond adequately to at least two different treatments. Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression are not helped by the first antidepressant medication they try. Up to a third of people with depression are failed by multiple attempts at treatment.

The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line 6-week (primary endpoint) COMP005 data is expected in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026.

About the COMP004 Trial
The COMP004 trial is a 52-week observational follow-up study on sixty-six participants from COMP001 (n=58 of which 22 participants were in the 25 mg arm, 19 participants were in the 10 mg arm and 17 participants were in the 1 mg arm) and COMP003 (n=8) trials to explore the long-term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP003. Following completion of COMP001 or COMP003, as applicable, study participants had the option to enroll in COMP004 and there was a low rate of enrollment into COMP004. The analyses based solely on participants who enrolled in COMP004 are limited by the resulting selection bias.

About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

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.

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 cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. The forward-looking statements 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 Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials, including that the results from this long-term follow-up study may not be predictive of the results for our phase 3 program in TRD; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. 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 for updating or revising any forward-looking statements contained in this press release in the event 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318973265/en/

Contacts

Enquiries
Media: Media, media@compasspathways.comInvestors: Stephen Schultz,
stephen.schultz@compasspathways.com, +1 401 290 7324

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

www.businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

NetApp Storage Now Validated for NVIDIA DGX SuperPOD, NVIDIA Cloud Partners, and NVIDIA-Certified Systems18.3.2025 22:00:00 EET | Press release

NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that NVIDIA has validated high-performance NetApp enterprise storage systems with NetApp ONTAP® for environments powering AI training and inferencing. For the first time, with NetApp, customers can now get the benefits of validated configurations and architectures for NVIDIA—including NVIDIA DGX SuperPOD, NVIDIA Cloud Partners, and NVIDIA-Certified Storage—combined with the rich and mature data management services in NetApp ONTAP critical for building AI factories. These certifications ready NetApp to tap the NVIDIA AI Data Platform reference design for NetApp ONTAP to advance storage infrastructure with AI agents for reasoning model inference workloads, powered by NVIDIA accelerated computing, networking, and software. “NetApp and NVIDIA are longstanding technology partners, jointly serving hundreds of customers for AI model training and inferencing,” said Jonsi Stefansson, Senior Vice President and C

NetApp Fuels Future of Agentic AI Reasoning Solutions with NVIDIA AI Data Platform18.3.2025 22:00:00 EET | Press release

NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced it is advancing the state of the art in agentic AI with intelligent data infrastructure that taps the NVIDIA AI Data Platform reference design. By collaborating with NVIDIA, NetApp is enabling businesses to better leverage their data to fuel AI reasoning inference. In the era of intelligence, businesses need to rethink their data strategies to turn rapidly growing data estates into competitive assets that empower them to agilely navigate their business environment. By adopting an Intelligent Data Infrastructure framework, businesses will be able to operate under a unified vision that integrates metadata cataloging, automation, and hybrid cloud capabilities to eliminate siloes and deliver actionable insights at every stage of the AI pipeline. Together, NetApp ONTAP® and the NVIDIA AI Data Platform enable businesses to navigate the era of intelligence by building distributed systems that unlock the full

Outseer Launches Platformized Behavioral Biometrics Delivering Unmatched Defense in Depth18.3.2025 21:52:00 EET | Press release

Outseer, a recognized leader in authentication and fraud prevention for digital banking and 3-D Secure (3DS) transactions, announced its platform-native Behavioral Biometrics capability today. The addition of platformized Behavioral Biometrics introduces another layer of defense that continuously analyzes user interactions to detect anomalies in real time. Building on its rich RSA® heritage (formerly RSA Fraud & Risk Intelligence™), Outseer has enhanced its platform to meet today’s dynamic threat landscape. As fraud evolves—spurred by the digitization of payments, the spread of personal data across the dark web, the growing threat of scams and authorized fraud, as well as advancements like GenAI—Outseer’s multi-signal risk engine, leveraging sophisticated machine learning algorithms and AI, sets a new standard for continuous, unified protection. “Our customers are facing rising authorized and unauthorized fraud threats in digital banking and 3DS transactions, requiring fraud solutions

Ravenna Becomes the First Colourblind-Friendly City in Italy: Event and New EnChroma Glasses Donation18.3.2025 18:29:00 EET | Press release

Tomorrow, March 19, 2025, at 4:30 PM, the conference "How Colourblind People See" will be held at the Martini Hall of MAR – Ravenna’s Museum of Art. This event is dedicated to raising awareness about colour blindness and the challenges of colour perception. Speakers will include Stefano De Pietro, President of the Italian Association "How Colourblind People See", and Sandor Breznay, President of the Breznay-Ganoczy Foundation (Agno, Switzerland) and the Paolina Brugnatelli Foundation (Milan). Colour blindness affects approximately 1 in 12 men and 1 in 200 women, with over 300 million people worldwide experiencing this condition—2.5 million in Italy. While those with normal colour vision can distinguish over a million shades, individuals with colour vision deficiency see only about 10% of those hues. As a result, colours may appear dull or even indistinguishable. This initiative aims to increase public awareness and make cultural and educational experiences more accessible for those wit

Accelera hosts Spanish Prime Minister and industry leaders for tour and meeting at Guadalajara electrolyzer facility18.3.2025 18:10:00 EET | Press release

Accelera™ by Cummins, the zero-emissions business segment of Cummins Inc. [NYSE: CMI], hosted Spanish Prime Minister Pedro Sánchez and other government officials at its state-of-the-art electrolyzer manufacturing facility in Guadalajara, Castilla-la Mancha, Spain. The visit highlighted Accelera's important role in enabling the European Union (EU) and Spain's energy transition toward a sustainable future. Following Prime Minister Sánchez’s visit, Accelera held a meeting with top industry executives to explore opportunities for advancing the Spanish green hydrogen market together. The Government of Spain is committed to the green transition, with green hydrogen as one of its pillars. The decisive policies promoted by the Executive have allowed 20% of green hydrogen projects in Europe to be promoted in Spain. Prime Minister Sánchez toured the 260,000 square-foot proton exchange membrane (PEM) electrolyzer manufacturing facility, one of the largest in Spain, and met with Accelera employees

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye