LONDON, Dec. 19, 2023 (GLOBE NEWSWIRE) -- 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 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
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