Compass Pathways’ COMP360 psilocybin shows positive efficacy, tolerance results

Compass Pathways (CMPS) announced the publication of results from an open-label Phase 2 study evaluating the safety and tolerability of a single-dose of 25 mg of investigational COMP360 synthetic psilocybin treatment in 22 patients with post-traumatic stress disorder, or PTSD. The Phase 2 study findings, previously disclosed in May 2024, show that COMP360 was well tolerated and indicated both rapid and durable improvement in symptoms from baseline observed out to 12 weeks following a single administration. The international Phase 2 study was conducted across three sites in the U.K. and the U.S. The study findings were published in the Journal of Psychopharmacology. Administration was well tolerated, with no serious adverse events observed. There were no treatment-emergent serious adverse events. Durable improvement in symptoms from baseline observed out to 12 weeks following a single administration. Improvement in mean CAPS-5 total score from a baseline of 47.5 was observed – 29.9 point reduction at week 4 and 29.5 point reduction at week 12 -. Improvement over time in Sheehan Disability Scale measure of functional impairment over 12 weeks. From a mean SDS total score of 22.7 at baseline, there was a 11.7 point reduction at week 4 and a 14.4 point reduction at week 12. High and sustained rates of response and remission relative to baseline, with early onset of symptom improvement. PTSD affects approximately five percent of adults in the U.S. annually. Symptoms may appear within months of the trauma or be delayed, and they must persist for over a month and interfere with daily functioning to meet diagnostic criteria.