Compass’ twin clinical updates regarding its lead candidate spotlight the promise of psychedelic medicine.
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Compass Pathways, a U.K.-based mental health care company, announced two critical clinical updates Thursday regarding its lead product candidate, COMP360, which exhibited encouraging results as a treatment for both type II bipolar disorder and treatment-resistant depression (TRD).
Compass announced these twin clinical updates as part of its presentations at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP).
COMP360 is a synthetic form of psilocybin, which is a hallucinogenic compound found within some species of fungi.
Compass is trialing the so-called “psychedelic medicine” as a potential ground-breaking therapy for various hard-to-treat forms of depression. COMP360 is administered in a controlled setting in conjunction with psychological support.
A Possible Breakthrough in Type II Bipolar Disorder
On the type II bipolar disorder front, COMP360 produced an 86% (12 out of 14 patients) remission rate in a small, open-label pilot study. Equally as important, Compass noted in its press release that responders went into remission for three months following a single course of treatment with 25mg of COMP360.
The psychedelic medicine also did not elicit an elevated level of adverse events in the open-label study. As psilocybin is currently a Schedule I substance in the Controlled Substances Act, the therapy’s safety profile will undoubtedly receive an extra level of scrutiny by U.S. regulators.
In the wake of these promising early-stage results, study leader Scott Aaronson, M.D., chief science officer at the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Baltimore, said “these findings now need to be validated in larger studies”.
Although a battery of medicines currently exists for the treatment of type II bipolar disorder, patients rarely show an immediate response to pharmaceutical interventions. What’s more, most patients have to experiment with a variety of medicines before finding one that works.
COMP360, while still in early stage development, might turn out to be a game-changer for this hard-to-treat mental health disorder.
COMP360 Continues to Impress in TRD
Also at ACNP, Compass released new findings from COMP360’s published Phase IIb study results in TRD patients. The key takeaway is that COMP360 appears to alter behavioral patterns in people with depression via a positive psychedelic experience that facilitates an emotional breakthrough.
Based on its positive Phase IIb results, Compass advanced COMP360 into a registration-enabling Phase III trial last month. Topline results from this high-profile trial are on track to be released in the fourth quarter of 2024.
TRD has proven to be one of the hardest mental health indications to successfully drug. So, if COMP360 can succeed where so many others have failed, this novel therapeutic could turn out to be a major revenue generator for the clinical-stage biopharma.
