At a Glance
- Company: Compass Pathways plc (Nasdaq: CMPS)
- Location: London, UK (with US offices)
- Headline figures: 3.8-point MADRS reduction (25 mg vs 1 mg, p<0.001); 39% clinically meaningful response
- Focus area: Treatment-resistant depression (TRD) using synthetic psilocybin COMP360
- Next steps: FDA meeting for rolling NDA submission in Q4 2026
What happened?
Compass Pathways announced top-line results from its phase 3 COMP006 trial, the second pivotal study of COMP360 psilocybin therapy for treatment-resistant depression (TRD). The trial met its primary endpoint with a highly statistically significant 3.8-point reduction in MADRS scores at week 6 for two 25 mg doses versus 1 mg control (p<0.001). This follows a first phase 3 win (COMP005) last year showing a 3.6-point reduction with a single dose.
Why does it matter?
TRD affects millions with few effective options, and COMP360 offers rapid onset (day 1) and durable effects up to 26 weeks from one or two doses, potentially setting a new standard over daily antidepressants. As the first classic psychedelic with consistent phase 3 efficacy across over 1,000 participants, it addresses a profound unmet need in psychiatry. Shares rose over 30% post-announcement.
Who’s behind it?
Compass Pathways, a London-based biotech (Nasdaq: CMPS), develops evidence-based mental health innovations, focusing on COMP360 with FDA Breakthrough Therapy designation for TRD. CEO Kabir Nath and CMO Dr. Guy Goodwin led the announcement.
How was it achieved?
In COMP006, 581 participants with TRD received two fixed doses of COMP360 (25 mg, 10 mg, or 1 mg) three weeks apart in a double-blind trial across North America and Europe. 39% in the 25 mg arm achieved ≥25% MADRS reduction, with effects sustained through week 6. Safety was favourable: most adverse events (headache, nausea) mild, resolved within 24 hours; low suicidality (<1%). Durability data from COMP005 showed persistence to week 26.
What’s next?
Compass requested an FDA meeting for rolling NDA submission, targeting completion in Q4 2026 with expedited review. COMP006 26-week data expected early Q3 2026; ongoing work in PTSD.
What are people saying?
“COMP360 is safe to try and… if you respond, on average, you do so on day one,” said CEO Kabir Nath. Evercore analysts: “looks like an approvable drug” due to strong durability.