Compass Pathways has announced encouraging results from the first phase 3 trial of their synthetic psilocybin drug, COMP360, designed to treat treatment-resistant depression (TRD). The randomized, double-blind, placebo-controlled COMP005 study involved 258 participants across 32 sites in the United States.
The trial tested a single 25 mg dose of COMP360 against a placebo to evaluate its effectiveness in reducing depression symptoms. The primary measure was the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score six weeks after treatment. Results showed a statistically significant and clinically meaningful improvement in patients receiving COMP360 compared to placebo, with an average difference of -3.6 points in MADRS scores (P<0.001).
Kabir Nath, CEO of Compass Pathways, highlighted the significance of these findings, saying, “These positive results demonstrate the potential of psilocybin in mental health care and reflect our dedication to advancing treatment options for patients with TRD.”
This trial is notable as the first phase 3 study of a synthetic classic psychedelic to report efficacy data. A second phase 3 trial, COMP006, is currently underway with plans to enroll 568 participants in North America and Europe. COMP006 will compare the safety and efficacy of two fixed doses of COMP360 (25 mg and 10 mg) administered three weeks apart, with results expected in late 2026.
Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways, expressed optimism about the progress: “This milestone offers new hope for patients who have not responded to existing treatments and underlines the innovative approach we are taking to improve mental health care.”
The Independent Data Safety Monitoring Board overseeing the trial reported no unexpected safety concerns or significant differences in suicidal thoughts between the treatment and placebo groups.
Compass Pathways plans to share these preliminary results with the US Food and Drug Administration (FDA) as they continue to develop COMP360 as a new treatment option for depression.
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