Psilocybin therapy shows promise in treating depression: Phase 3 trials
Compass Pathways's new synthetic psilocybin therapy just delivered some good news for people struggling with tough-to-treat depression.
In two big Phase 3 trials, their drug COMP360 helped many patients who hadn't responded to regular treatments finally see real improvement.
In the 1st trial, a single high dose of COMP360
In the first trial, a single high dose of COMP360 led to a noticeable drop in depression symptoms by week six—25% of participants in the 25 mg arm achieved a 'clinically meaningful' MADRS reduction (>=25%) at week six, and the benefits kicked in fast and stuck around for months.
The 2nd study tested 2 doses spaced 3 weeks apart
The second study tested two doses spaced three weeks apart and showed similar results: another significant dip in symptoms.
In COMP005, over 40% of those who achieved a clinically meaningful MADRS reduction but had not remitted by Week 6 went into remission after the second dose.
That's a big deal if nothing else has worked.
Compass has requested a meeting with the FDA
Compass has requested a meeting with the FDA to discuss a rolling submission, asked for expedited review, and aims to complete an NDA in Q4.
Safety checks looked solid so far, with no major concerns flagged.
CEO Kabir Nath called these results "a remarkable achievement," hinting at hope for those still searching for answers.