Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

• Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
• Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
• 81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
• Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

“These results, with early and lasting improvement in symptoms following a single administration of COMP360, are highly encouraging,” said Dr. Guy Goodwin, Chief Medical Officer of Compass Pathways. “These observations, even with a small, open-label study, suggest that COMP360 could provide a clinically meaningful benefit and substantially improve patient daily function and quality of life. The well tolerated safety profile for COMP360 in patients with PTSD, with no serious adverse events observed, advance our understanding of potential applications of COMP360. We look forward to submitting the full results of this study for publication and potential presentation at an upcoming medical conference.”