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Compass Pathways Shares Topline 52-week Results (Part C) From Its Phase 3 COMP005 Trial Of Comp360 For Treatment-Resistant Depression, Showing Additional Benefit Extending Durability Out To 1 Year

Benzinga·09/09/2026 10:37:22

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Notable additional benefit observed with an added reduction in MADRS1 score leading to an average 13-point reduction from baseline at Week 52 with durability extended out to 1 year for participants who were randomized to the 25 mg arm and received an additional dose
For participants randomized to Placebo arm who received first dose of COMP360 25 mg in open-label Part C, data further reinforces that a single 25 mg dose can produce rapid onset, meaningful effect and durability
For all participants in Part C who received a 25 mg open-label dose, strong response and remission rates were observed with 40%-45% responders2 and approximately 30% remitters3 across all timepoints 6 weeks post the Part C dose
This 1-year data further supports the belief that, if approved, COMP360 could establish a new standard of care in TRD that can be life-changing for patients − moving beyond daily or frequent administration toward an option that could provide durable benefit with just a few treatments a year
COMP360 safety profile in Part C is consistent with Parts A and B. COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings
Rolling NDA submission and review underway and final submission on track to be completed in Q4
Continue to expect commercial launch in first half of 2027