* UK sites to participate in part of pivotal phase 3 program following
Medicines and Healthcare Regulatory Agency approval of study
* Research will take place in the UK, including at the newly opened Centre for

    Mental Health Research and Innovation in London, developed in partnership
    with South London and Maudsley NHS Foundation Trust and the Institute of
    Psychiatry, Psychology & Neuroscience at King's College London

LONDON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS)
("Compass"), a biotechnology company dedicated to accelerating patient access to
evidence-based innovation in mental health, today announced the initiation of
the UK component of its phase 3 program of investigational COMP360 psilocybin
treatment in treatment-resistant depression (TRD). The research will take place
in multiple sites in the UK, including at the Centre for Mental Health Research
and Innovation ("the Centre") in London, which officially opened today.
The ongoing phase 3 program is the largest randomized, controlled, double-blind
psilocybin treatment clinical program ever conducted and follows promising
results from Compass's phase 2b study of COMP360 psilocybin treatment. The phase
3 program consists of two pivotal trials (COMP 005 and COMP 006), and each trial
has an integrated, long-term outcomes component.
COMP 006 will take place in the UK and globally and will study three dose arms
of COMP360 (25mg, 10mg and 1mg). COMP 005 is a US-based trial examining the
effect of a single 25mg dose of COMP360 psilocybin, compared with placebo.
Research at the new Centre for Mental Health Research and Innovation
The COMP 006 trial will be conducted at research sites across the UK, including
at the new Centre for Mental Health Research and Innovation, which officially
opened today.
The Centre was established to accelerate psychedelic research and develop new
models of care for mental health in the UK, as part of a pioneering long-term
strategic partnership between Compass, South London and Maudsley NHS Foundation
Trust, and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at
King's College London.
Located at the Maudsley Hospital in South London, the dedicated and purpose-
built space will be run by leading clinical investigators, Professor Allan
Young, Head of Academic Psychiatry at King's College London, and Dr James
Rucker, Consultant Psychiatrist and Lead of the Psychoactive Trials Group at
King's College London. Research will initially focus on areas of urgent need,
including TRD and anorexia nervosa.
The Centre will assist in the development of new models of care to help
integrate these investigational treatments into health systems, if approved in
the future. This will include evaluating real-world evidence, researching and
developing digital technologies that may help to deliver personalized,
predictive and preventative care models, and conducting therapist training.
Commentary
"Every 40 seconds, someone dies from suicide; tens of millions more live with
mental health conditions for which there is no good standard of care," said
Kabir Nath, CEO, Compass Pathways. "The launch of our phase 3 clinical study in
treatment-resistant depression here in the UK is an important step in developing
innovations that are urgently needed, and we recognize the important role that
public-private partnerships play in this."
Kabir continued, "We're proud to partner with South London and Maudsley NHS
Foundation Trust and King's College London to open the new Centre for Mental
Health Research and Innovation. Together, we are conducting cutting-edge
research to develop new solutions for mental illnesses and ensure these
potential treatments are broadly and equitably accessible to those who need them
the most."
David Bradley, Chief Executive of South London and Maudsley NHS Foundation
Trust, said, "We are excited to be running part of this pivotal phase 3 study at
the new Centre for Mental Health Research at our Maudsley Hospital site in South
London."
He continued, "The newly launched Centre is part of a research
partnership which will help to develop innovative treatment with the goal of
improving mental health care for people across the UK. Our world-leading
clinicians will work closely with researchers at the new Centre and will begin
with a focus on areas of urgent need, such as anorexia nervosa and treatment-
resistant depression."
Professor Allan Young, Head of Academic Psychiatry, at King's College London
said: "Today marks a milestone for research into the use of psychedelics to
treat mental health conditions. Over several years we have moved to phase 3
clinical trials for psilocybin and treatment-resistant depression, an
achievement that would not have been possible without the facilities and staff
of the NIHR King's Clinical Research Facility. Now with this new Centre, the
continuing partnership between Compass Pathways, King's College London and South
London and Maudsley is embarking on the next stage of research where we can
evaluate the safety and effectiveness of psychedelics to treat a range of mental
health conditions, explore the mechanisms behind how psychedelics might work and
assess the feasibility for their delivery at scale."
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is dedicated to accelerating patient access
to evidence-based innovation in mental health. Our focus is on improving the
lives of those who are suffering with mental health challenges and who are not
helped by current treatments. We are pioneering the development of a new model
of psilocybin therapy, in which our proprietary formulation of synthetic
psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug
Administration (FDA) and has received Innovative Licensing and Access Pathway
(ILAP) designation in the UK for treatment-resistant depression (TRD). We have
commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the
largest randomized, controlled, double-blind psilocybin therapy clinical program
ever conducted. Previously, we completed a phase 2b study with top line data
showing a statistically significant (pÂ