Compass Pathways announced the successful achievement of the primary endpoint in the ongoing phase 3 COMP006 trial, the second of two phase 3 trials, which is evaluating two fixed doses of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD).
The primary endpoint was the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the 25 mg and 1 mg groups at week 6. Two fixed doses — administered 3 weeks apart — of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in change at the primary endpoint.
The data confirms a statistically significant rapid onset from the day following administration and maintained at all measured timepoints through week 6 in both clinical trials in the 25 mg arm. COMP005 suggests that participants who demonstrated a clinically meaningful reduction in MADRS maintained durable treatment effect at least through week 26, after just one or two doses. Retreatment with a second dose was well-tolerated, with a consistent safety profile.
Compass has submitted a request for a meeting with the U.S. FDA to discuss a rolling submission and review.