COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health
care company dedicated to accelerating patient access to
evidence-based innovation in mental health, today announced that
new long-term efficacy data of investigational COMP360 psilocybin
in cancer patients with major depressive disorder will be presented
at the Annual Meeting of the American Society of Clinical Oncology
(ASCO).
More than half of the patients (16/28) treated with a single
dose of 25mg COMP360 psilocybin with psychological support remained
in remission from their depression at 18 months post
administration. The investigator-initiated study, led by Manish
Agrawal, MD, at Sunstone Therapies, is believed to be the longest
study of psilocybin therapy ever conducted.
The trial was a phase 2, single-center, fixed-dose, open-label
study in 30 patients with curable and incurable cancer and major
depressive disorder. Patients were treated with a single dose of
25mg of COMP360 psilocybin, administered simultaneously in group
cohorts of 3-4, with group and individual psychological support,
and evaluated at 8 weeks and 18 months. Of 30 patients from the
parent study, 28 were enrolled in the follow-up study. Key
results:
- 18/28 patients (64.2%) demonstrated
sustained clinical response from baseline to 18 months
follow-up
- 16/28 patients (57.1%) demonstrated
remission of depression at 18 months
The original phase 2 study conducted by Sunstone was completed
in 2021 and results were published in JAMA Oncology in April
2023.
Guy Goodwin, MD, Chief Medical Officer, COMPASS Pathways, said:
“This study conducted by Sunstone Therapies is extremely
encouraging and demonstrates the potential durability of COMP360
psilocybin therapy. COMPASS Pathways is looking at the long-term
effects of COMP360 in our phase 3 programme in treatment-resistant
depression.”
Manish Agrawal, MD, Chief Executive Officer, Sunstone Therapies,
and the trial’s Principal Investigator, said: “This pioneering
study is the first of its kind, conducted within a community
hospital cancer center. The results show significant improvement in
these patients’ depression symptoms long-term and, if replicated in
larger studies, could open the door to a wider and faster adoption
of psilocybin therapy in the future.”
COMP360 is COMPASS’s investigational proprietary formulation of
synthetic psilocybin, administered in conjunction with
psychological support. COMPASS is currently conducting a phase 3
clinical program of COMP360 psilocybin therapy in
treatment-resistant depression (TRD), the largest of its kind ever
conducted. This program follows positive results from COMPASS’s
phase 2b study published in the New England Journal of
Medicine.
About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care
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 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 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
(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”, “might”, “will”, “could”,
“should”, “expect”, “intend”, “plan”, “anticipate”, “believe”,
“estimate”, “predict”, “possible”, “potential”, “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 its investigational COMP360 psilocybin therapy, including for
treatment of TRD, anorexia nervosa, PTSD, and major depressive
disorder, COMPASS’s expectations regarding its ongoing preclinical
work and clinical trials and development efforts and COMPASS’s
expectations regarding investigator-initiated studies 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; the
possibility of unfavorable results from additional clinical trials
of COMP360 psilocybin therapy or from subsequent analysis of
existing data or new data received from additional ongoing and
future studies of COMP360 psilocybin therapy; 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 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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