COMPASS Pathways to fund study of COMP360 psilocybin in autistic adults

May 09, 2022 07:00 ET | Source: COMPASS Pathways

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

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