Compass Pathways plc (CMPS) announced Monday that its investigational psilocybin therapy, COMP360, met the primary endpoint in the Phase 3 COMP005 trial for treatment-resistant depression or TRD, showing statistically significant and clinically meaningful improvement in depression symptoms at six weeks.
A single 25 mg dose of COMP360 resulted in a mean reduction of 3.6 points in MADRS depression scores compared to placebo.
The study enrolled 258 patients across 32 U.S. sites and represents the first-ever Phase 3 trial of a classic psychedelic to report positive efficacy results.
An independent Data Safety Monitoring Board or DSMB found no new safety concerns, with no imbalance in suicidal ideation between COMP360 and placebo groups. The safety profile was consistent with prior trials of COMP360.
The COMP005 trial is part of Compass's broader Phase 3 program in TRD. A second trial, COMP006, is ongoing and will evaluate two doses of COMP360 taken three weeks apart.
26-week data from COMP006 are expected in the second half of 2026.
COMP360 is a proprietary, synthetic psilocybin formulation being developed as a potential first-in-class treatment for difficult-to-treat mental health conditions.
It has received Breakthrough Therapy designation from the FDA and ILAP designation in the UK.
Compass CEO Kabir Nath called the data "a significant milestone" and said the company plans to engage with the FDA on next steps.
The results were announced in advance of planned peer-reviewed publication and future medical meeting presentations.
Currently, CMPS is trading at $2.50, down by 46.11 percent on the Nasdaq.
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