Compass Pathways plc (NASDAQ:CMPS) on Wednesday reported 26-week results from Part B of its Phase 3 COMP006 trial, reinforcing the rapid and durable efficacy of COMP360, its synthetic psilocybin therapy for treatment-resistant depression (TRD).
The results were consistent with the earlier Phase 3 COMP005 study and support the company’s ongoing rolling New Drug Application with the U.S. Food and Drug Administration (FDA).
The 26-week analysis included nearly 600 patients with chronic TRD, whose current depressive episodes had lasted more than three years on average and who had experienced more than six lifetime depressive episodes.
Among patients receiving two fixed 25 mg doses of COMP360, 39% achieved at least a 25% reduction in their Montgomery-Åsberg Depression Rating Scale (MADRS) score by Week 6, with benefits maintained through at least Week 26.
By comparison, 25% of patients in the earlier COMP005 study achieved the same response after a single dose, suggesting a second dose may provide additional clinical benefit for some patients.
Safety Findings Remain Consistent
Compass said COMP006 had previously met its primary endpoint in Part A at Week 6 with statistically significant and clinically meaningful results. The company added that separation between the 25 mg and 1 mg treatment arms was maintained throughout the randomized, blinded Part B period through Week 26.
Among patients who achieved a clinically meaningful response at Week 6, nearly 30% later entered remission following retreatment during Part B, according to the company.
The safety profile also remained consistent with earlier studies.
FDA Submission Continues
Compass is rolling out a New Drug Application submission, and initial FDA review is underway, with the final submission expected in the fourth quarter of 2026.
Subject to FDA approval and Drug Enforcement Administration rescheduling, the company expects to launch COMP360 during the first half of 2027.
CMPS Stock Price Activity: Compass Pathways shares were down 7.24% at $11.91 at the time of publication on Tuesday, according to Benzinga Pro data.
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