LONDON, Dec. 06, 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 the publication of a
paper in
JAMA Psychiatry
(https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2812443) 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 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 (pÂ