Compass Pathways Reports Durable Six-Month Data from Second Phase III Trial of COMP360 Psilocybin for TRD
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
Compass Pathways has announced six‑month results from its second phase 3 trial of COMP360, its synthetic formulation of psilocybin, for treatment‑resistant depression. The new 26‑week data from the COMP006 study further supports COMP360’s rapid onset and durable effect, reinforcing findings from the earlier COMP005 trial.
Nearly 600 participants took part in COMP006, representing a highly chronic treatment‑resistant population. Participants had current depressive episodes lasting on average more than three years and had experienced more than six lifetime depressive episodes. In the 25mg arm, 39% achieved a clinically meaningful reduction in MADRS by week 6 after two fixed doses and maintained response through week 26. This compares with 25% in COMP005 following a single dose.
COMP360 continued to show a generally well‑tolerated and safe profile, with most adverse events being transient and occurring on the day of dosing.
A rolling New Drug Application submission with the US Food and Drug Administration is underway, with final submission expected in Q4 2026. Subject to approval and Drug Enforcement Administration rescheduling, Compass anticipates launching COMP360 in the first half of 2027.
The Chief Executive Officer of Compass Pathways stated that the COMP006 data further strengthens the clinical package for COMP360 and represents an important step toward completing the NDA submission. The Chief Medical Officer of Compass Pathways noted that COMP360 has demonstrated rapid, durable and reproducible clinical effects through at least six months across two large, well‑controlled phase 3 studies in TRD.