COMPASS Pathways has received approval from the US Food and Drug Administration (FDA) for a clinical trial in psilocybin therapy for treatment-resistant depression. Regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada.
The trial is a phase IIb dose-ranging study with 216 patients taking part in 12 to 15 research sites across Europe and North America. It will begin in the UK later this month and sites in other countries will join the trial as further regulatory approvals are received.
Psilocybin therapy combines a dose of psilocybin (a psychoactive medicine and the active ingredient in "magic mushrooms") with psychological support, and has shown promising signals of efficacy and safety as treatment for depression in academic studies in the UK and US. If the trial is successful, it will be followed by phase III studies.
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"We are excited to be starting this landmark trial which has the potential to transform lives. Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people,” George Goldsmith, Chairman and Co-founder of COMPASS Pathways, said. “It is a huge unmet need and the trial will teach us more about how this new approach might address it."
"The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North America working together with the goal of helping patients suffering with treatment-resistant depression," Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS, said.