Compass Pathways hit the primary endpoint in its ongoing Phase 3 COMP005 trial, the first of two phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD).
The trial’s primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. In the trial, a single dose of COMP360 25 mg, delivered in a capsule, versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint.
The phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the U.S., aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD.
Compass plans to discuss these preliminary COMP005 data with the U.S. FDA, which has not yet reviewed the data.