COMPASS Pathways to fund study of COMP360 psilocybin in autistic adults

London, UK – 9 May 2022

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it will be funding an investigator-initiated study that will use COMP360 psilocybin to explore how psilocybin affects specific brain pathways in autistic adults. This will be the first ever mechanistic study of psilocybin in autistic adults.

The double-blind, randomised, placebo-controlled study (“PSILAUT”) will investigate whether there is a difference in the function of serotonin brain networks in autistic and non-autistic adults. The researchers will use a range of imaging techniques and behavioural tasks to examine how the serotonin system is modulated by COMP360 psilocybin. It is an investigator-initiated exploratory study that will take place at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London. The study is co-sponsored by King’s IoPPN and South London and Maudsley NHS Foundation Trust. It will enrol 70 adult participants, including 40 autistic people and 30 non-autistic people.

The study is led by Professor Grainne McAlonan, Professor of Translational Neuroscience at King’s IoPPN, and conducted by Tobias Whelan, PhD student at King’s and Research Scientist at COMPASS Pathways. Tobias is also supervised by Professor Declan Murphy and Dr Nicolaas Puts from King’s IoPPN, who are investigators in the study. Professor Sir Simon Baron-Cohen and Dr Carrie Allison at the Autism Research Centre at the University of Cambridge are collaborators and external advisors.

Professor Grainne McAlonan, IoPPN, said: “I am delighted that COMPASS Pathways is supporting our investigations into the brain science of neurodiversity. Our long-term goal is to provide more and better tailored choices for autistic people and those with related conditions. Before embarking on clinical trials, we need to really understand brain mechanisms in autistic people.”

Professor McAlonan has previously led other studies in autism at King’s IoPPN. Klara, a participant on an earlier study, said: “My son and I both have autism, and this can be challenging at times. I’m pleased that researchers are looking into what makes an autistic brain different from a neurotypical one. It gives me hope that in the future, we might uncover new ways to support people and families who may need help, and that society becomes more accepting of people who are neurodiverse.”

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “We are pleased to fund this innovative research, the first of its kind using psilocybin in autistic adults. We hope that this study improves understanding of how the serotonin system is involved in autism. For autistic people who are seeking treatment for symptoms that are causing distress, this research may be the first step in finding new options.”

For information about taking part in the study, contact Tobias Whelan at mrs@kcl.ac.uk.

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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 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 a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). 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. 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. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. 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: preclinical research 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 annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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.        

About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience

King's College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King's has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and 8,500 staff. King's has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain. www.kcl.ac.uk/ioppn @KingsIoPPN

About South London and Maudsley NHS Foundation Trust

South London and Maudsley NHS Foundation Trust is a large and complex multi-site provider of mental health services – providing the widest range of NHS mental health services in the UK. We aim to make a difference to people’s lives by seeking excellence in all areas of mental health and wellbeing. Our 6,000 staff serve a local population of 1.3 million people and we offer more than 260 services including inpatient wards, outpatient and community services across Lambeth, Lewisham, Southwark and Croydon. We also provide substance misuse services for people who are addicted to drugs and alcohol. As well as serving the communities of south London, we provide more than 20 specialist services for children and adults across the UK including perinatal services, eating disorders, psychosis and autism. www.slam.nhs.uk @MaudsleyNHS

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

Video accompanying this announcement is available at:
https://www.youtube.com/embed/0clDfStSBK8