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
new paper in Pyschopharmacology, which showed the results of a
retrospective study that evaluates the potential of its AI
technologies to support investigational COMP360 psilocybin
treatment in treatment-resistant depression (TRD). The paper was
published on August 22, 2023.
The peer-reviewed paper shows the AI model has the potential to
predict outcomes of the investigational COMP360 psilocybin
treatment in people with TRD up to 12 weeks after treatment using
recordings taken during the integration session 24 hours post
administration. Further research and studies are required to
validate this model and to evaluate its capabilities to predict
responder status pre-treatment.
Using a large language model, COMPASS created a machine learning
algorithm that assessed the emotional sentiment of 101 English
speaking participants from the company’s recent randomized
double-blind phase 2b study in TRD. The sentiment scores, as
measured by valence (happiness to sadness) and arousal (intensity
of emotion), were then used in the second stage of the machine
algorithm to predict patient response as measured by the
Montgomery-Asberg Depression Rating Scale (MADRS) at three weeks
and three months post-drug administration. This model yielded a
cross-validated accuracy of 85% and 88% at the three and
twelve-week timepoints, respectively. The Area Under the Curve
(AUC) results were comparable with values of 88% and 85% at the
three and twelve-week timepoints.
“These results are exciting because they signal that we could
potentially use AI technology to predict long-term patient response
in the emerging field of psilocybin treatment,” said Kabir Nath,
CEO of COMPASS Pathways. “We believe this could also support the
delivery of more personalized care in the long-term for people
suffering from TRD.”
“Our goal is to use technology to move clinical psychology
toward precision medicine,” said Greg Ryslik, Chief Technology
Officer at COMPASS. “By using Natural Language Processing (NLP) to
identify key linguistic and speech-based digital biomarkers, we
have the opportunity to further understand the presentation of TRD
and help provide a deeper understanding of treatment-resistant
depression as a whole if unique patterns between individuals
emerge.”
About COMPASS Pathways
COMPASS 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
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(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 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”, “believe”, “estimate”,
“predict”, “possible”, “potential” 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, COMPASS’s expectations regarding the potential
benefits of its AI model and its ability to develop technologies
that may predict treatment outcomes, the safety or efficacy of its
investigational COMP360 psilocybin treatment, including for
treatment of TRD, anorexia nervosa, and PTSD, COMPASS’s
expectations regarding its ongoing preclinical work and clinical
trials and development efforts, the potential for COMPASS’s pivotal
phase 3 program or other trials to support regulatory filings and
approvals and COMPASS’s expectations regarding the benefits of its
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: the outcomes of future studies of this AI model are
uncertain and may never establish the accuracy or reliability of
such technology; 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 treatment or from subsequent
analysis of existing data or new data received from additional
ongoing and future studies of COMP360 psilocybin treatment; 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 efforts to obtain
coverage and reimbursement for our investigational COMP360
psilocybin therapy, 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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