Compass Pathways COMP360 Shows 3.8-Point MADRS Gain and 40% Remission Rate
Phase 3 studies showed a 3.8-point MADRS advantage for the 25 mg COMP360 dose over 1 mg at week six with statistical separation by day two. In a subset, 40% of patients entered remission after a second administration with benefits durable through 26 weeks and a Spravato-style REMS planned with FDA.
1. Phase 3 Efficacy Results
Compass Pathways reported that in COMP005 and COMP006, the 25 mg COMP360 dose achieved a statistically significant 3.6–3.8-point improvement on the MADRS scale versus placebo or 1 mg comparator at week six, with separation evident by day two post-dosing.
2. Durability and Remission Outcomes
In longer-term follow-up, a subset of patients retained clinically meaningful benefit—defined as at least 25% MADRS reduction—through 26 weeks, and approximately 40% of individuals receiving a second administration entered remission, indicating potential for repeat dosing to deepen response.
3. Regulatory Path and Safety Framework
The company expects a REMS program similar to Spravato and describes constructive FDA engagement with no shortcuts taken during development. The 25 mg dose is prioritized for regulatory filing, while the 10 mg dose remains under secondary consideration and is being explored in PTSD trials.