Compass Pathways plc announced on April 22, 2025, the completion of dosing for all participants in Part A of its Phase 3 COMP005 trial for treatment-resistant depression (TRD). This milestone follows the earlier completion of recruitment for the trial on March 26, 2025. Participants received a single dose of either 25 mg of COMP360 or placebo after completing pre-dosing activities.
The COMP005 trial is the largest multi-center study of an investigational, synthesized psilocybin to complete recruitment and dosing. It involved 258 participants with moderate-to-severe depression who had not responded to at least two prior treatments, across 32 sites in the United States. The trial aims to assess the efficacy and safety of COMP360 25 mg versus placebo.
This achievement marks a critical operational milestone, bringing the company closer to delivering a potential new treatment option for TRD patients. Compass Pathways remains on track to disclose the top-line 6-week primary endpoint results for the COMP005 trial in late June 2025.
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