Psychedelics

COMPASS Pathways announces publication in Frontiers in Psychiatry
of paper on therapist training programme for psilocybin therapy

Formal and scalable methodology for psychological support in psilocybin therapy

London, UK 3 February 2021


COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has shared details of its comprehensive and rigorous therapist training programme for psilocybin therapy, in a paper jointly written with a group of academic researchers, and published in Frontiers in Psychiatry today. The programme sets out a formal and scalable methodology for psychological support in psilocybin therapy. It is currently being used to train therapists taking part in COMPASS's phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression, as approved by the US Food and Drug Administration (FDA), as part of COMPASS's Investigational New Drug (IND) application.

In psilocybin therapy, patients are given a dose of psilocybin, a psychedelic substance, in conjunction with psychological support from specially trained therapists. COMPASS developed the therapist training programme alongside leading experts in mental health and psychedelic research, including William A Richards (Johns Hopkins Bayview Medical Center, US), Elizabeth Nielson (NYS Psychiatric Institute, NYU School of Medicine, US), Riikka Ajantaival (Clinical Research Institute, Helsinki University Central Hospital, Finland), Peter Gasser (private practice, Switzerland), Sara J Tai (University of Manchester, UK), Brian D Richards (Johns Hopkins Bayview Medical Center, Sheppard and Enoch Pratt Hospital, and Aquilino Cancer Center, US), and Frederick Reinholdt (King's College London, UK). The programme uses a new and manualised approach drawing from evidence-based psychotherapeutic approaches, and currently comprises four components: an online learning platform; in-person training; applied clinical training; and ongoing individual mentoring and professional development.

In previous psilocybin studies, the approach to psychological support often varied between research sites, making it difficult to replicate and distinguish the specific effects of psilocybin from concurrent therapeutic interventions. Equally, training in the provision of psychological support had not been defined and evaluated. This manualised training programme begins to address this gap and is the start of a process that will continue to be refined and adapted as clinical trials of psilocybin therapy progress.

Dr William A Richards, a psychologist and research affiliate in the Psychiatry Department of the Johns Hopkins University School of Medicine, Bayview Medical Center, and a co-author of the paper, said, "The psychological support is an integral element of psilocybin therapy and must be provided by trained therapists. The development of a structured and formalised training programme aims to ensure we deliver psilocybin therapy in a way that considers physical and psychological safety, with consistently high quality support."

Therapists who participated in the training reported that the combination of didactic and experiential learning helped them to build conceptual understanding and develop their skills in the therapeutic approach. From the programme feedback, the clinical training and engagement in participant care, under the guidance of experienced therapists, were considered to be the most beneficial and challenging aspects of the training.

Ekaterina Malievskaia, Chief Innovation Officer and Co-founder, COMPASS Pathways, said, "Psilocybin therapy has the potential to make a difference to millions of people suffering with mental health challenges, and our priority is to develop evidence-based innovations that are safe and effective for patients. High quality clinical training for therapists is an essential part of this. Our training programme is the result of early and ongoing collaboration with many experts and we are grateful for all their contributions. We will continue to evolve our training programme as we progress COMP360 psilocybin therapy through clinical trials. We hope that this first step encourages collaboration among therapist training providers, as we work towards bringing psilocybin therapy to all who might benefit."

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 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 are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using 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 fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed 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 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. 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, the risk that benefits of our methodology of psychological support in psilocybin therapy may be less effective than we believe, that preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic, and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the 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.

Media enquiries:
Tracy Cheung, tracy@compasspathways.com , +44 7966 309024


Investor enquiries:
Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324


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