Compass Pathways’ Psilocybin-Based Therapy Reaches Key Milestone in Depression Trial

LOS ANGELES- Compass Pathways has announced that its lead candidate, COMP360, achieved the primary endpoint in a Phase 3 clinical trial evaluating its efficacy in treatment-resistant depression (TRD). In the COMP005 study, involving 258 participants across 32 U.S. sites, a single 25 mg dose of COMP360 demonstrated a statistically significant reduction in depressive symptoms compared to placebo, based on the Montgomery-Åsberg Depression Rating Scale (MADRS). The trial marks the first time a synthetic psilocybin has shown positive results in a late-stage clinical setting for a major depressive disorder.

Despite the clinical milestone, Compass shares fell sharply in pre-market trading, with investors reportedly concerned about the modest degree of symptom improvement. The study’s safety profile was deemed acceptable, with no unexpected adverse events or imbalance in suicidal ideation. The company plans to continue with its ongoing COMP006 trial, which will assess the effects of two fixed doses over 26 weeks, and is preparing for discussions with the U.S. Food and Drug Administration. The outcome positions Compass as a leading developer in the emerging field of psychedelic-assisted therapies.