COMPASS Pathways Receives FDA Approval for Psilocybin Therapy Clinical Trial for Treatment-resistant Depression

London (ots/PRNewswire) -

COMPASS Pathways (https://compasspathways.com/), a life sciences
company dedicated to accelerating patient access to evidence-based
innovation in mental health, 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.

(Logo:
https://mma.prnewswire.com/media/733890/COMPASS_Pathways_Logo.jpg )

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.

George Goldsmith, Chairman and Co-founder of COMPASS Pathways,
said, "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. It is a huge unmet
need and the trial will teach us more about how this new approach
might address it."

Ekaterina Malievskaia, Chief Medical Officer and Co-founder of
COMPASS, said: "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."

About COMPASS Pathways

COMPASS Pathways is a life sciences company, founded in 2016 to
accelerate patient access to evidence-based innovation in mental
health. We are developing psilocybin therapy through a late-stage
clinical trial in Europe and North America 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.

http://www.compasspathways.com

Enquiries:

Tracy Cheung, tracy@compasspathways.com , +44-7966-309024

Chris Strutt, chris@compasspathways.com , +44-7850-546135

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