Compass Pathways announces investigational COMP360 psilocybin treatment was well-tolerated in phase 2 study of post-traumatic stress disorder
19 Dicembre 2023 - 10:05PM
Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology
company dedicated to accelerating patient access to evidence-based
innovation in mental health, today announced that an initial data
readout showed that investigational COMP360 psilocybin treatment
was well-tolerated in a phase 2 clinical trial of people living
with post-traumatic stress disorder (PTSD). This is believed to be
the first study reporting on the feasibility of psilocybin as a
potential treatment for PTSD.
The open-label study evaluated the safety and tolerability of
COMP360 psilocybin treatment in patients with PTSD as a result of
trauma experienced as adults. 22 participants received a single
25mg dose of investigational COMP360 psilocybin treatment. The
initial data readout, based on monitoring patients at 24 hours post
COMP360 administration, indicated that COMP360 was well-tolerated
and the safety profile was as expected, with no treatment emergent
serious adverse events recorded.
In line with the study design, participants are being monitored
for a 12-week period post dosing. Safety and efficacy data over
that period are expected to be announced in spring 2024. The study
is being conducted in the UK and US at The Institute of Psychiatry,
Psychology & Neuroscience at King’s College London, Icahn
School of Medicine at Mount Sinai, New York City and Sunstone
Therapies, Rockville, Maryland.
Dr Guy Goodwin, Chief Medical Officer, Compass Pathways, said:
“Safety is of paramount importance when developing potential new
treatments, so we are pleased to see these positive safety signals.
These results are consistent with findings from other studies and
add to the growing body of evidence to demonstrate the potential of
COMP360 in difficult-to-treat mental health conditions.”
Dr James Rucker, Consultant Psychiatrist and Lead of the
Psychoactive Trials Group at King’s College London, said: “PTSD is
a very distressing condition and existing treatments are not always
effective. It’s encouraging to see these initial safety results for
COMP360 psilocybin treatment in this patient population and we look
forward to a more detailed analysis of the study next year.”
About Compass PathwaysCompass Pathways plc
(Nasdaq: CMPS) is a biotechnology company 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 treatment, 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 COMP360
psilocybin treatment in TRD, the largest randomized, controlled,
double-blind psilocybin treatment 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 25mg dose of COMP360
psilocybin with psychological support. We are also conducting phase
2 clinical studies of COMP360 psilocybin treatment for
post-traumatic stress disorder (PTSD) and anorexia nervosa.
Compass 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. www.compasspathways.com
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
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others interested in us to review the information that is posted on
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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
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website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Forward-looking statementsThis 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 treatment 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 ability to continue to
advance its research, obtain regulatory approval or develop plans
to bring COMP360 psilocybin treatment to patients, and Compass’s
expectations regarding the benefits of its investigational COMP360
psilocybin treatment. 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: full results from this phase 2
study in post-traumatic stress disorder or results from future
studies may not be consistent with the preliminary results to date,
clinical development is lengthy and outcomes are uncertain, and
therefore our clinical trials may be delayed or terminated; the
results early-stage clinical trials of our investigational COMP360
psilocybin treatment may not be predictive of the results of later
stage clinical trials; 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,
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.
Enquiries Media: Amy Lawrence,
media@compasspathways.com, +44 7813 777 919 Investors: Stephen
Schultz, stephen.schultz@compasspathways.com, +1 401 290
7324
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