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 InnovationThe 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 PathwaysCompass 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 (p<0.001) and
clinically relevant improvement in depressive symptom severity
after three weeks for patients who received a single high dose of
COMP360 psilocybin with psychological support. We are also
conducting phase 2 clinical studies of COMP360 psilocybin therapy
for post-traumatic stress disorder (PTSD) and anorexia nervosa.
Compass Pathways is headquartered in London, UK, with offices in
New York and San Francisco in the United States. Our vision is a
world of mental wellbeing.
Availability of other information about Compass
Pathways
Investors and others should note that we communicate with our
investors and the public using our website
(www.compasspathways.com), our investor relations website
(ir.compasspathways.com), and on social media (LinkedIn), including
but not limited to investor presentations and investor fact sheets,
US Securities and Exchange Commission filings, press releases,
public conference calls and webcasts. The information that we post
on these channels and websites could be deemed to be material
information. As a result, we encourage investors, the media, and
others interested in us to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. This list of channels may be updated from time to
time on our investor relations website and may include additional
social media channels. The contents of our website or these
channels, or any other website that may be accessed from our
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Forward-looking statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. In some cases, forward-looking statements can be
identified by terminology such as “may”, “will”, “could”, “would”,
“expect”, “intend”, “plan”, “anticipate”, “believe”, “potential”
and “continue” and “ongoing,” or the negative of these terms or
other comparable terminology, although not all forward-looking
statements contain these words. Forward-looking statements include
express or implied statements relating to, among other things, the
safety or efficacy of investigational COMP360 psilocybin therapy as
a treatment for depression, post-traumatic stress disorder or
anorexia nervosa, the potential for the pivotal phase 3 program or
other trials to support regulatory filings and approvals, Compass’s
business strategy and goals, Compass’s expectations and plans
regarding the Centre for Mental Health Research and Innovation,
Compass’s ability to continue to advance its research or develop
plans to bring COMP360 psilocybin therapy to patients, including
COMP360, and Compass’s expectations regarding the benefits of its
investigational COMP360 psilocybin therapy. The forward-looking
statements in this press release are neither promises nor
guarantees, and you should not place undue reliance on these
forward-looking statements because they involve known and unknown
risks, uncertainties, and other factors, many of which are beyond
Compass’s control and which could cause actual results, levels of
activity, performance or achievements to differ materially from
those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among
others: clinical development is lengthy and outcomes are uncertain,
and therefore our clinical trials may be delayed or terminated; our
efforts to obtain marketing approval from the applicable regulatory
authorities in any jurisdiction for COMP360 or any of future
product candidates may be unsuccessful, our development efforts and
our business strategy to set up research facilities and innovation
labs, such as the Centre for Mental Health Research and Innovation
involves significant costs and resources and may be unsuccessful;
and our efforts to obtain coverage and reimbursement for our
investigational COMP360 psilocybin treatment, if approved, may be
unsuccessful; and those risks and uncertainties described under the
heading “Risk Factors” in Compass’s most recent annual report on
Form 10-K or quarterly report on Form 10-Q and in other reports we
have filed with the U.S. Securities and Exchange Commission (“SEC”)
, which are available on the SEC’s website at www.sec.gov. Except
as required by law, Compass disclaims any intention or
responsibility for updating or revising any forward-looking
statements contained in this press release in the event of new
information, future developments or otherwise. These
forward-looking statements are based on Compass’s current
expectations and speak only as of the date hereof.
About King’s College London and the
Institute of Psychiatry, Psychology &
Neuroscience
King’s College London is amongst the top 35 universities in the
world and top 10 in Europe (THE World University Rankings 2023),
and one of England’s oldest and most prestigious universities.
With an outstanding reputation for world-class teaching and
cutting-edge research, King’s maintained its sixth position for
‘research power’ in the UK (2021 Research Excellence
Framework).
King's has more than 33,000 students (including more than 12,800
postgraduates) from some 150 countries worldwide, and some 8,500
staff. The Institute of Psychiatry, Psychology & Neuroscience
(IoPPN) at King’s is a leading centre for mental health and
neuroscience research in Europe. It produces more highly cited
outputs (top 1% citations) on psychiatry and mental
health than any other centre (SciVal 2021), and on
this metric has risen from 16th (2014) to 4th (2021) in the world
for highly cited neuroscience outputs. In the 2021 Research
Excellence Framework (REF), 90% of research at the IoPPN was deemed
‘world-leading’ or ‘internationally excellent’ (3* and
4*). World-leading research from the IoPPN has made, and
continues to make, an impact on how we understand, prevent and
treat mental illness, neurological conditions, and other conditions
that affect the brain.
www.kcl.ac.uk/ioppn | Follow
@KingsIoPPN on Twitter, Instagram, Facebook
and LinkedIn
About South London and Maudsley NHS Foundation
Trust
South London and Maudsley NHS Foundation Trust is a large and
complex multi-site provider of mental health services – providing
the widest range of NHS mental health services in the UK. We aim to
make a difference to people’s lives by seeking excellence in all
areas of mental health and wellbeing.
Our 6,000 staff serve a local population of 1.3 million people
and we offer more than 260 services including inpatient wards,
outpatient and community services across Lambeth, Lewisham,
Southwark and Croydon. We also provide substance misuse services
for people who are addicted to drugs and alcohol.
As well as serving the communities of south London, we provide
more than 20 specialist services for children and adults across the
UK including perinatal services, eating disorders, psychosis and
autism. Find out more about our five-year strategy Aiming High;
Changing Lives https://slam.nhs.uk/strategy
Enquiries Media: Amy Lawrence,
media@compasspathways.com, +44 7813 777 919 Investors: Stephen
Schultz, stephen.schultz@compasspathways.com, +1 401 290
7324
A video accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/f821f711-519f-4768-9cc5-bd43242fa05e
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