Compass Pathways Reports 3.8-Point MADRS Improvement and Six-Month Durability
Compass Pathways’ Phase 3 COMP360 25 mg arm achieved a statistically significant 3.8-point MADRS improvement versus active comparator by week six, with separation apparent from day two. A subset of patients maintained clinically meaningful benefit through 26 weeks and nearly 40% reached remission after a second administration, supporting regulatory filing plans.
1. Phase 3 Efficacy Results
In the COMP005 and COMP006 trials, the 25 mg COMP360 dose produced statistically significant separation on the MADRS scale versus placebo or 1 mg comparator beginning on day two and sustained through the six-week primary endpoint, with a peak difference of 3.6–3.8 points at week six.
2. Durability through 26 Weeks
Data from the COMP005 Part B follow-up show that a subset of patients maintained at least a 25% reduction in MADRS scores through 26 weeks, and 40% of those receiving a second administration entered remission, indicating potential for durable and deepened antidepressant response.
3. Regulatory and Commercial Strategy
Executives report constructive engagement with the FDA’s Division of Psychiatry and plan to center their filing and launch on the 25 mg dose with a safety framework similar to Spravato’s REMS, while positioning the 10 mg option as secondary and exploring it in a PTSD trial.
4. Dose Options and Next Steps
Although clinician interest exists in a 10 mg dose, only the 25 mg arm consistently met statistical and clinical thresholds; upcoming data from the 52-week Part C follow-up will further inform durability, and additional patient-level analyses are expected to clarify repeat dosing benefits.