COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy 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 Breakthrough Therapy
designation from the US Food and Drug Administration (FDA) for its
psilocybin therapy for treatment-resistant depression.

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The FDA designates a drug as a Breakthrough Therapy if preliminary
clinical evidence shows that it may demonstrate substantial
improvement over available therapy. Breakthrough Therapies are
supported by the FDA throughout the clinical development programme to
ensure as efficient a process as possible.

Breakthrough Therapy designation is a significant milestone for
psilocybin therapy and psilocybin research, and a testament to the
work done over many years by research teams in the US, the UK and
Switzerland. The Heffter Research Institute was the first to fund
research in this field, and supported early studies at Johns Hopkins
University, New York University, and Harbor-UCLA. In the UK, the
Medical Research Council backed the proof-of-concept study of
psilocybin for treatment-resistant depression at Imperial College
London in 2015. COMPASS Pathways is now running the first large-scale
psilocybin therapy clinical trial for treatment-resistant depression,
which will take place in Europe and North America over the next year
or so.

George Goldsmith, Executive Chairman, COMPASS Pathways, said,
"This is great news for patients. We are excited to be taking this
work forward with our clinical trial on psilocybin therapy for
treatment-resistant depression. The FDA will be working closely with
us to expedite the development process and increase the chances of
getting this treatment to people suffering with depression as quickly
as possible."

Treatment-resistant depression is a huge unmet need, affecting 100
million people around the world who do not respond to existing
treatments. Depression is one of the fastest growing health problems
we face today, and the leading cause of ill-health and disability
worldwide. The Breakthrough Therapy designation for psilocybin
therapy highlights the importance of supporting early research that
can be translated to clinically meaningful outcomes.

Dr Robin Carhart-Harris, Head of the Psychedelic Research Group,
Imperial College London, said, "In our 2015 study, we provided
psilocybin to 19 patients in a clinical setting, coupled with
psychological support, and found promising signals of efficacy and
safety as treatment for treatment-resistant depression. The
Breakthrough Therapy designation is a strong endorsement for the
potential of psilocybin therapy. We look forward to learning more as
further clinical studies are carried out, by our team at Imperial
College as well as in COMPASS's multi-centre trial."

Dr David Nichols, Chairman of the Board, Heffter Research
Institute, said, "Since its inception in 1993, Heffter has been
helping to design, review, and fund the early phase clinical studies
on psilocybin at research institutions in the US and Europe. We are
delighted that psilocybin is being recognised as a Breakthrough
Therapy and look forward to continuing our work with researchers and
partners around the world so that we can alleviate the suffering
caused by mental illness."

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.
www.compasspathways.com

Enquiries:

Tracy Cheung, tracy@compasspathways.com , +44-7966-309-024

Chris Strutt, chris@compasspathways.com , +44-7850-546-135

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