COMPASS Pathways Partners with Worldwide Clinical Trials to Conduct World’s First Large-scale Clinical Trials in Psilocybin Therapy for Treatment-resistant Depression

COMPASS Pathways, a healthcare company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it is partnering with Worldwide Clinical Trials to conduct a major programme of late-stage clinical trials for psilocybin therapy for treatment-resistant depression.

Depression is the leading cause of ill-health and disability worldwide, and one of the fastest growing health problems, affecting more than 300 million people around the world.

George Goldsmith, Executive Chairman and Co-Founder, COMPASS Pathways, said, “We need a new approach to tackling mental health. Current treatments for depression work for many people but there is still a significant unmet need for a large number of patients living with this very challenging condition.

“COMPASS is making rapid progress with plans to develop psilocybin therapy for patients suffering with treatment-resistant depression. Several small, exploratory academic studies have already shown the promise of psychoactive medicine. With Worldwide as our Clinical Research Organisation (CRO) partner, we will have the extensive experience and deep expertise needed to conduct the first ever large-scale randomised, controlled trials, covering 400 patients with treatment-resistant depression in eight countries.”

The trial will begin in the first quarter of 2018 and is planned to include clinical sites in Czech Republic, Finland, Germany, the Netherlands, Norway, Portugal, Spain and the UK.

“The Worldwide team is delighted to have been selected as COMPASS’ CRO partner,” said Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials. “Worldwide and COMPASS share a commitment to medical and scientific expertise, evidence-based innovation, and new ways of working, centred around the patient. We are looking forward to working together on this exciting new therapy, which could significantly improve the lives and long-term outcomes of patients suffering with treatment-resistant depression.”

The selection of a CRO and development of clinical trial sites are the latest in a series of successful milestones for COMPASS, which completed pre-clinical trials and manufacturing to Good Manufacturing Practice (GMP) standards earlier this year. COMPASS was founded two years ago. The company is backed by a group of accomplished and successful investors, including Christian Angermeyer, Galaxy Investment Partners led by Mike Novogratz and Sam Englebardt, and Peter Thiel. COMPASS is also supported by a team of highly respected expert advisers (see below).

About COMPASS Pathways

COMPASS Pathways is a healthcare company, founded in 2015 to accelerate patient access to evidence-based innovation in mental health. We are developing psilocybin therapy through late-stage clinical trials in the EU and US for patients with treatment-resistant depression. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology.

COMPASS Pathways expert advisers

Professor Sir Alasdair Breckenridge CBE FRSE

• Former Chairman, UK Medicines & Healthcare products Regulatory Agency
• Chairman, Centre of Regulatory Excellence Advisory Board

Robin Carhart-Harris PhD

• Head of Psychedelic Research, Faculty of Medicine at Imperial College London
• First author on psilocybin clinical trial for treatment-resistant depression, Imperial College (2016)

Mike Emmanuel

• Former VP Global Clinical Operations for Europe, Middle East & Africa, Janssen Pharmaceuticals
• Former Associate Director, UK National Institute for Health Research Clinical Research Network

Professor Guy Goodwin FMedSci

• WA Handley Professor of Psychiatry
• Former Chair, Department of Psychiatry, University of Oxford
• Former President, European College of Neuropsychopharmacology

Professor Charles Grob MD

• Director of the Division of Child and Adolescent Psychiatry at the Harbor-UCLA Medical Center

Tom Insel MD

• President and Co-Founder, Mindstrong Health
• Former Lead, Verily Mental Health team
• Former Director, US National Institute of Mental Health

Marco Mohwinckel

• Vice President of Strategy, WebMD Health Group
• Former Global Head, Janssen Solutions and Janssen Healthcare Innovation

David Nichols PhD

• Professor Emeritus of Pharmacology, Purdue University

Professor Augustus John Rush MD

• Professor Emeritus of University of Texas Southwestern Medical Center and Duke-NUS Graduate Medical School
• Recipient of Thomson Reuters: World’s Most Influential Scientific Minds (2014)
• American Psychiatric Association (APA): Award for Research in Psychiatry (2007)

Paul Summergrad MD

• Chairman, Psychiatry Department, Tufts University School of Medicine
• Former President, American Psychiatric Association

About Worldwide Clinical Trials

Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From early phase and bioanalytical sciences through late phase and post-approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID) and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit Worldwide.com.

About depression and treatment-resistant depression

• Depression is one of the fastest growing health problems we face today, and the leading cause of ill-health and disability worldwide. At its worst, it can lead to suicide
• The WHO estimates that more than 300 million people worldwide are living with depression, an increase of 18% between 2005 and 2015. Of these, about 100 million people suffer with treatment-resistant depression (TRD)
• Around 25% of people in the EU suffer from anxiety and depression
• The European Brain Council believes that across the EU, the total annual cost of depression is €118 billion
• Patients with TRD are likely to have higher medical costs and be associated with lower productivity and quality of life, for themselves and their families

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Contact information

COMPASS Pathways:
Tracy Cheung
+44 7966 309024
tracy@compasspathways.com,
or
Chris Strutt
+44 7850 546135
chris@compasspathways.com
or
Worldwide Clinical Trials:
Sherri Stuart, Vice President, Global Marketing and Communications
+1 610-563-8768
Sherri.Stuart@worldwide.com