COMPASS Pathways has presented new, positive data demonstrating the potential of COMP360 psilocybin therapy in depression at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP).
The results were presented from an investigator-initiated, exploratory open-label study of investigational COMP360 psilocybin therapy in type II bipolar disorder, and a mechanistic analysis of the phase 2b trial of COMP360 psilocybin therapy in treatment-resistant depression (TRD).
Chief Medical Officer at COMPASS Pathways, Dr Guy Goodwin, stated: “These studies provide further evidence to support COMP360 psilocybin therapy’s potential for difficult-to-treat depression.
“Psilocybin binds to serotonin receptors in the brain, and by allowing different brain regions to connect and communicate more easily than usual, it produces a profound psychedelic experience.
“This experience is driven by drug dose and correlates with the effect on depressive symptoms. Psychological support is focused on safety, which facilitates the psychedelic experience, but does not directly drive the effect on depression: it is not a psychotherapy.”
Type II bipolar disorder
Positive early signals have been presented in a poster from an open-label pilot study, which investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin therapy in participants with type II bipolar disorder depression.
The study, run by Dr Scott Aaronson at Sheppard Pratt Baltimore, found that 86% of the participants met response and remission criteria for the Montgomery-Åsberg Depression Rating Scale (MADRS) at 12 weeks after COMP360 psilocybin therapy.
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.
Scott Aaronson, MD, Chief Science Officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, commented: “Type II bipolar disorder can have a huge impact on people’s lives, as well as their loved ones, and is extremely difficult to treat.
“It is really encouraging to have seen 12 of 14 participants go into remission lasting three months, following just a single dose of 25mg of COMP360 psilocybin therapy. These findings now need to be validated in larger studies.”
Treatment-resistant depression
New data from the recently published phase 2b trial of COMP360 psilocybin therapy, also presented at ACNP, further demonstrated its potential in treatment-resistant depression, and how it may work.
COMPASS has confirmed that results saw predicted reductions in depression severity three weeks after receiving COMP360 psilocybin therapy, and that the relationship between positive psychedelic experience and treatment response was seen for all three doses studied.
It also confirmed that whilst both 10mg and 25mg doses of COMP360 psilocybin produced a subjective psychedelic experience, the 25mg dose was significantly better at reducing depressive symptoms compared to a 1mg dose, whereas the 10mg dose was not found to be significantly better than 1mg.
Additionally, in regards to psychological support, the therapeutic alliance between the participant and therapist did not predict improvement in symptoms of depression, suggesting that COMP360 psilocybin may provide greater therapeutic effect via its pharmacological action.
COMPASS says that this hypothesis will be tested further in COMPASS’ Phase 3 programme.
Dr David Feifel, Principal Investigator in the COMPASS phase 2b study at Kadima Neuropsychiatry Institute, La Jolla, California, said: “The positive results published in the New England Journal of Medicine showed the efficacy of COMP360 psilocybin in treatment-resistant depression, and now these new findings are providing insights on how that antidepressant effect may be produced.
“This new analysis suggests that positive psychedelic experiences facilitate emotional breakthrough which may change thought patterns in people with depression.”
The company is now running the world’s first phase 3 programme of COMP360 psilocybin therapy in treatment-resistant depression.
