Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology
company dedicated to accelerating patient access to evidence-based
innovation in mental health, today announced the publication of a
paper inJAMA Psychiatry that demonstrates the potential for
investigational COMP360 psilocybin treatment in treatment-resistant
bipolar type II disorder (bipolar II). Results from the
investigator-initiated open-label study were first presented at the
Annual Meeting of the American College of Neuropsychopharmacology
in 2022.
The study, which was conducted by Dr Scott Aaronson at Sheppard
Pratt, Baltimore, and funded by Compass, investigated the safety
and efficacy of a single 25mg dose of COMP360 psilocybin treatment
in participants with treatment-resistant bipolar II. The primary
endpoint was change in Montgomery-Åsberg Depression Rating Scale
(MADRS) total score from baseline to week 3. All participants (n =
15) had lower MADRS scores with a mean change from baseline of
-24.0 points at week 3, 12 participants met the response criteria
and 11 met the remission criteria.
There was no increase in the suicidality score based on the
MADRS, no manic symptoms and no unexpected adverse events or
difficulties with the dosing sessions reported throughout the
study. The most common adverse event was headache reported by 4 out
of 15 participants on the day of dosing, with symptoms resolving
within 24 hours.
“We’re pleased that our study has been recognized and published
by a highly regarded peer-reviewed journal,” said Dr Scott
Aaronson, MD, Chief Science Officer, Institute for Advanced
Diagnostics and Therapeutics, Sheppard Pratt. “In what we believe
to be the first study of its kind, we saw a significant number of
patients experience relief from their bipolar II depression
symptoms after a single 25mg dose of COMP360 psilocybin treatment.
These findings need to be validated in larger studies.”
Dr Guy Goodwin, Chief Medical Officer, Compass Pathways, said:
“Bipolar II can be extremely difficult-to-treat and if medicines
don’t provide adequate relief, it can be even more challenging to
live with. We are committed to finding solutions for those living
with mental illness who have limited or no options, so it’s
encouraging to see early signals that COMP360 psilocybin may have
potential to help those living with the condition.”
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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but not limited to investor presentations and investor fact sheets,
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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
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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”, “could”, “expect”, “plan”,
“believe”, “potential”, “promise”, “signal”, “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 or bipolar II depression, 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 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: clinical development is lengthy and outcomes are uncertain,
and therefore our clinical trials may be delayed or terminated; the
results early-stage clinical trials or investigator-initiated
studies of our investigational COMP360 psilocybin treatment or any
future therapeutic candidates 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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