Compass Pathways announced positive 26-week results from its second Phase 3 trial (COMP006) for COMP360, its psilocybin treatment for treatment-resistant depression (TRD). The data confirmed a rapid onset and durable response, reinforcing the drug's profile ahead of a planned regulatory submission.
Key Details
- Efficacy Data: In the 25mg arm, 39% of participants achieved a clinically meaningful reduction in depression symptoms (MADRS score) by week 6 and maintained a durable response through week 26.
- Regulatory Timeline: A rolling New Drug Application (NDA) submission to the FDA is underway, with final submission on track for Q4 2026. The company anticipates a commercial launch in the first half of 2027, pending approval.
- Safety Profile: COMP360 was generally well-tolerated and safe, consistent with previous studies. The majority of adverse events were transient and occurred on the day of dosing, with no new safety signals identified.