07:10 AM EDT, 06/23/2025 (MT Newswires) -- Compass Pathways ( CMPS ) said Monday its phase 3 COMP005 trial of COMP360, a synthetic psilocybin formulation, met its primary endpoint in patients with treatment-resistant depression.

A single 25 mg dose of COMP360 led to a "statistically significant" and "clinically meaningful" reduction in depression severity compared with placebo at six weeks as measured by the Montgomery-Asberg Depression Rating Scale, the company said.

The trial included 258 participants at 32 US sites. Safety results were consistent with earlier studies, with no new or unexpected issues, including no meaningful difference in suicidality between treatment groups.

The company said enrollment for its second phase 3 COMP006 trial is continuing, with 26-week data expected in the second half of next year.