Positive data from phase
IIb study shows potential of
COMP360 psilocybin therapy in treatment-resistant
depression
London, UK – 23 May
2022 COMPASS
Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care
company dedicated to accelerating patient access to evidence-based
innovation in mental health, today presented positive data from the
largest randomised, controlled, double-blind study of psilocybin
therapy ever completed, at the American Psychiatric Association
annual meeting in New Orleans*. The study showed that a single 25mg
dose of COMP360 psilocybin, in combination with psychological
support, was associated with a highly statistically significant
reduction in depressive symptoms after three weeks (p<0.001),
with a rapid and durable response for up to 12 weeks.
The randomised, controlled, double-blind phase IIb clinical
trial was designed to understand the efficacy and safety of a
single dose of investigational COMP360 psilocybin (25mg or 10mg),
compared to 1mg in patients with treatment-resistant depression
(TRD). 233 patients with TRD received either 1mg, 10mg or 25mg
COMP360 psilocybin, in conjunction with psychological support from
specially trained therapists. Symptoms of depression were assessed
using the Montgomery-Åsberg depression rating scale (MADRS)**, a
widely used and accepted scale for assessing depression; the MADRS
assessments were made by an independent, blinded rater.
Key results:
- Depression symptoms: patients who received a
25mg dose of COMP360 psilocybin with psychological support
experienced a highly statistically significant reduction in
symptoms of depression after three weeks: the difference between
25mg group and 1mg group was -6.6 on the MADRS* depression scale at
week 3, p<0.001.
- Durability: double the number of patients who
received 25mg had a sustained response at week 12, compared to
those who received 1mg (20.3% of patients in the 25mg group vs
10.1% in the 1mg group).
- Tolerability: COMP360 psilocybin was generally
well-tolerated. On the day of COMP360 administration, headache,
nausea, and dizziness were the only adverse events where a
dose-related increase in incidence was evident and there were no
clinically significant differences between dose group in vital
signs or clinical laboratory tests observed during the study.
- Adverse events: In this study suicidal
ideation and intentional self-injury were seen in all treatment
groups (as is regularly observed in a TRD population), and the
majority occurred more than a week after the psilocybin session.
There was no mean worsening of suicidal ideation scores in any
treatment group. Suicidal behaviours were reported at least 1 month
after COMP360 administration for 3 non-responders in the 25mg
arm.
David J Hellerstein MD, a Principal Investigator
on the trial and Professor of Clinical Psychiatry at the Columbia
University Irving Medical Center, said: “Treatment-resistant
depression is one of the biggest challenges we face in psychiatry,
and chances of success decreases with each treatment that a patient
tries. It’s rare to see such positive outcomes of clinical trials
in this disease area, which is why these results are so
significant. I hope this represents a major step in finding new
options for people living with treatment-resistant depression.”
Dr Guy Goodwin, Chief Medical Officer, COMPASS
Pathways, said, “Our mission is all about developing mental health
innovations through scientific evidence, which is why we’re so
honoured to present the largest study of its kind at the APA. In
this study, a significant number of patients experienced
improvement in their symptoms of depression after just a single
dose of 25mg psilocybin with psychological support, with effects
lasting for up to three months of the study. We now need to
continue our research to understand if this can be replicated in
even larger trials.”
-Ends-
*The safety and efficacy of COMP360 psilocybin
therapy in treatment-resistant depression: Results from a phase IIb
randomized controlled trial. Guy M. Goodwin, Susan C. Stansfield,
David J. Hellerstein, Allan H. Young, Ekaterina Malievskaia. APA:
Abstract Number: 5301 Session Title: Poster Session 6
**MADRS = Montgomery-Åsberg Depression Rating
Scale; response = ≥50% decrease in MADRS total score from baseline;
remission = MADRS total score ≤10; sustained response = patients
meeting the MADRS response criteria from week 3 until week 12
About treatment-resistant depression
(TRD)
More than 320 million people globally suffer
with major depressive disorder (MDD)1, the leading cause of
disability worldwide and one of the fastest growing mental health
illnesses2. About a third of these patients – 100 million people –
aren’t helped by existing therapies and suffer with
treatment-resistant depression (TRD)3. As many as 30% of these
attempt suicide at least once during their lifetime4,5. TRD carries
two to three times the medical costs of a non-TRD MDD patient, and
patients with TRD have a higher all-cause mortality compared with
non-TRD MDD patients6. The TRD population is by definition more
difficult to treat and more likely to relapse than patients with
major depressive disorder. In 2018, COMPASS received FDA
Breakthrough Therapy designation for its COMP360 psilocybin therapy
for TRD.
About the COMP360 psilocybin therapy
phase IIb study
This randomised, controlled, multicentre,
double-blind phase IIb trial is the largest psilocybin therapy
clinical trial ever conducted, with 233 patients from 10 countries
in North America and Europe. 94% of the patients had no prior
experience with psilocybin. The objective of the trial was to find
the appropriate dose for a larger, pivotal phase III programme,
which COMPASS expects to begin in 2022.
The trial assessed the safety and efficacy of
COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total
of 233 patients enrolled in the study and were randomised and
blinded into three arms comprising 79 patients for each of the 25mg
and 1mg doses, and 75 patients for the 10mg dose. Patients were
followed up for 12 weeks. The trial used the Montgomery-Åsberg
depression rating scale (MADRS), a widely used and accepted scale
for assessing depression; assessments were made by an independent,
blinded rater. The primary endpoint was the change in the MADRS
total score from baseline to week 3.
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 US Food and Drug Administration (FDA),
for treatment-resistant depression (TRD), and we have completed a
phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites
across Europe and North America. This was the largest randomised,
controlled, double-blind psilocybin therapy clinical trial ever
conducted, and our topline data showed 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 running a phase II clinical trial of COMP360 psilocybin
therapy for post-traumatic stress disorder (PTSD). COMPASS is
headquartered in London, UK, with offices in New York and San
Francisco in the US. Our vision is a world of mental wellbeing.
www.compasspathways.com
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COMPASS Pathways
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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”, “would”, “should”, “expect”, “intend”, “plan”,
“objective”, “anticipate”, “believe”, “contemplate”, “estimate”,
“predict”, “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 COMP360 psilocybin therapy
as a treatment for depression, COMPASS’s business strategy and
goals, including its ability to launch and commercialise products,
COMPASS’s ability to continue to advance its research or develop
plans to bring its product candidates to patients, including
COMP360, and COMPASS’s expectations regarding the benefits of its
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: preclinical research and clinical
development is lengthy and uncertain, and therefore our preclinical
studies and clinical trials may be delayed or terminated, or may
never advance to or in the clinic; and those risks and
uncertainties described under the heading “Risk Factors” in
COMPASS’s annual report on Form 10-K filed with the US Securities
and Exchange Commission (SEC) on 24 February 2022 and in subsequent
filings made by COMPASS with the 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.
EnquiriesMedia: Amy Lawrence,
amy@compasspathways.com, +44 7813 777
919 Investors:
Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290
7324
References:
[1] WHO (2017). Depression and Other Common Mental Disorders
Global Health Estimates [Online]. Available at:
https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
[Accessed 21 October 2021][2] WHO (2012). Depression: A Global
Crisis [Online]. Available at:
https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf
[Accessed 21 October 2021][3] Al-Harbi KS. Treatment-resistant
depression: therapeutic trends, challenges, and future directions.
Patient Preference and Adherence. 2012; 6: 369–388.[4] Bergfeld IO,
Mantione M, Figee M, Schuurman PR, Lok A, Denys D.
Treatment-resistant depression and suicidality. Journal of
Affective Disorders. 2018;235:362-367[5] Dong M, Lu L, Zhang L, et
al. Prevalence of suicide attempts in bipolar disorder: a
systematic review and meta-analysis of observational studies.
Epidemiology and Psychiatric Sciences. 2020;29:e63[6] Gang L, Fife
D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with
treatment-resistant depression: a cohort study in the US
population. Annuals of General Psychiatry. 2019; 18:23.
Video accompanying this announcement is available
at: https://www.youtube.com/embed/k4EerZeZJHM
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