Compass Pathways announced 26-week results (Part B) from its second ongoing phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD), confirming the drug’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 also demonstrated rapid onset and durable response to at least 6 months.
COMP360's phase 3 program enrolled a notably treatment-resistant population — in COMP006, participants had current depressive episodes averaging over three years, with more than six lifetime episodes on average. Against that backdrop, 39% of patients receiving two 25 mg doses achieved a clinically meaningful MADRS2 reduction (≥25%) by week 6, with response sustained through at least week 26 — outperforming the 25% response rate seen after a single dose in COMP005 and suggesting a second dose may boost benefit for some patients.
A rolling NDA submission and initial review with the FDA 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