COMPASS Pathways, a healthcare company dedicated to accelerating patient access to evidence-based innovation in mental health, announced that it is partnering with Worldwide Clinical Trials to conduct a major program 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 CRO partner, we will have the extensive experience and deep expertise needed to conduct the first ever large-scale randomized, 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 U.K.

“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).