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Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression
LONDON & NEW YORK, June 23, 2025--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Ås
About this update from Compass, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"A single administration of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS1 with a mean difference of -3.6 comparing 25 mg to placebo (p<0.001)2","length":232,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Independent Data Safety Monitoring Board (DSMB) reviewed safety data for COMP360 and found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and placebo arms","length":215,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Ongoing pivotal Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic3, to report Phase 3 efficacy data","length":169,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Second ongoing pivotal Phase 3 COMP006 trial continues to enroll well, with 26-week data expected in the second half of 2026","length":124,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":740,"olType":false},{"type":"text","content":"LONDON & NEW YORK, June 23, 2025--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The Company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data.","length":1009,"tagName":"p"},{"type":"text","content":"The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy ...