COMPASS Pathways plc

COMPASS Pathways plc is a biotechnology company focused on developing innovative treatments for mental health conditions. The company is developing COMP360 psilocybin treatment, a proprietary formulation of pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. This investigational treatment aims to provide rapid and durable responses for serious mental health conditions, including treatment-resistant depression (TRD), a subset of major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). The initial focus is on TRD, addressing patients not adequately served by current treatments. In 2018, COMPASS Pathways received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for COMP360 for TRD. In November 2021, the company announced positive top-line results from its Phase 2b clinical trial evaluating COMP360 for TRD. These results were published in The New England Journal of Medicine on November 3, 2022. This Phase 2b study, the largest randomized, controlled, double-blind psilocybin treatment clinical trial completed to date, evaluated the efficacy and safety of a single dose of COMP360 (25mg or 10mg) compared to 1mg in TRD patients. The trial met its primary endpoint for the 25mg dose, showing a statistically significant and clinically relevant reduction in depressive symptom severity after three weeks against the 1mg dose. In 2025, the company completed enrollment for both pivotal trials in its Phase 3 program for COMP360 in TRD, each including a long-term follow-up component.