- Compass Pathways (CMPS, Financial) achieves primary endpoint in Phase 3 trial for COMP360 psilocybin treating treatment-resistant depression (TRD).
- COMP360 demonstrated statistically significant and clinically meaningful reduction in depression symptoms compared to placebo.
- Safety data review showed no unexpected safety concerns or imbalance in suicidality between treatment and placebo groups.
Compass Pathways plc (CMPS) announced a major milestone in its Phase 3 COMP005 trial for treatment-resistant depression (TRD) using COMP360 psilocybin, a synthetic formulation. The trial, conducted across 32 sites in the United States with 258 participants, demonstrated a statistically significant improvement in symptom severity over six weeks, achieving a mean difference of -3.6 on the Montgomery-Ã…sberg Depression Rating Scale (MADRS) compared to placebo, with a p-value of less than 0.001.
An independent Data Safety Monitoring Board (DSMB) reviewed the safety data and found no unexpected safety issues or a clinically meaningful imbalance in suicidal ideation between the treatment and placebo groups.
The ongoing COMP005 is one part of the company's pivotal Phase 3 program, which includes the COMP006 trial. The COMP006 trial is enrolling participants and is expected to deliver its 26-week data in the latter half of 2026. The program aims to assess COMP360's safety and efficacy, with plans to discuss these promising preliminary data with the U.S. Food and Drug Administration (FDA).
Compass Pathways continues to advance its mission of bringing innovative treatments for mental health conditions, leveraging evidence-based innovations to address the unmet needs of patients with TRD.
