Compass Pathways Announces 26-Week Results of COMP360 Trial

Compass Pathways announced the 26-week results from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression which confirm COMP360's rapid onset and durable profile. The 26-week findings in nearly 600 patients build on previously reported results from the first Phase 3 trial, COMP005, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD. The COMP360 Phase 3 program participants represent a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within the context of this severe population, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS2 by week 6, following two fixed doses of COMP360, and maintained durable response at least through Week 26. This compares favorably to the 25% in COMP005 following a single dose, supporting the potential value of a second dose in enhancing clinical benefit for some patients. COMP360 continues to demonstrate a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events being transient and predominantly occurring on day of dosing. A rolling New Drug Application submission and initial review with the U.S. Food and Drug Administration is underway and final submission remains on track to be completed in Q4, 2026. Compass anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration rescheduling. COMP006 Part A successfully met its primary endpoint at Week 6, delivering highly statistically significant and clinically meaningful results. Rapid onset of effect was observed, with consistent separation between the 25 mg and the 1 mg arm maintained through the randomized, blinded Part B period to Week 26. 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS at Week 6, maintaining benefit, on average, through at least Week 26. Retreatment in Part B further enhanced benefit: nearly 30% of participants who achieved a clinically meaningful response at Week 6 later went into remission3 following retreatment in Part B. Together with COMP005, the COMP006 26-week data confirm a consistent, differentiated profile for COMP360, with rapid onset and durable benefit observed across two large, well-controlled Phase 3 studies in TRD. In a highly chronic TRD population with long-lasting depressive episodes, and consistent with previous studies, COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings. Majority of TEAEs were transient and predominantly occurring on day of dosing. Most common adverse events were nausea, headache, anxiety and visual hallucination. Serious adverse events were similar across arms over 26 weeks but low overall across the trial.