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.
Kabir Nath, Chief Executive Officer of Compass Pathways, said: “The COMP006 data further strengthens our robust clinical package for COMP360 and represents an important step toward completing our NDA submission.
“COMP360 has demonstrated consistent results, with rapid onset and durable benefit for people living with chronic, treatment‑resistant depression. We are convinced this profile will lead to a profound shift in mental health care — moving beyond daily or frequent administration towards an option potentially involving just a few treatments in a year that could be life changing for patients.”
Dr Guy Goodwin, Chief Medical Officer of Compass Pathways, said: “We are grateful to the hundreds of participants across our phase 3 program along with the sites, providers and caregivers who have made it possible for us to generate data supporting the safety and efficacy of COMP360.
“COMP360 has demonstrated rapid, durable and reproducible clinical effects through at least six months — with a consistent safety profile — across two large, well‑controlled phase 3 studies in TRD. Against a high level of chronicity and treatment resistance, this achievement at scale is remarkable in one of psychiatry’s most underserved patient populations.”
Tobias Marton MD PhD, Chief Medical Officer of Mindful Health Solutions, said: “At Mindful Health Solutions we work with many patients struggling with chronic, severe depression who have failed to respond to standard antidepressants. The latest results from Compass’ COMP006 Part B mark an important step towards bringing a novel class of therapeutics to the many patients in need.
“With 39% of patients achieving a clinically meaningful response after two doses of psilocybin – an effect maintained for an average of six months – and almost 30% of those responders going into remission in the treatment interval, these results are exciting.”
