Compass Pathways presents new COMP360 psilocybin therapy data

Compass Pathways announced that new data demonstrating the potential of COMP360 psilocybin therapy in depression have been presented at the annual meeting of the American College of Neuropsychopharmacology, or 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, or TRD. 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 Scott Aaronson at Sheppard Pratt Baltimore, found that 86% of the participants met response and remission criteria for the Montgomery-Asberg Depression Rating Scale, or 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. 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: Mechanism of action validated: experiencing emotional breakthrough and specific aspects of the subjective psychedelic experience predicted reductions in depression severity three weeks after receiving COMP360 psilocybin therapy. The relationship between positive psychedelic experience and treatment response was seen for all three doses studied. Effect of higher dose: whilst both the 10mg and 25mg dose 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. 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. This hypothesis will be tested further in COMPASS’ phase 3 program.