The results were consistent with the earlier Phase 3 COMP005 study and support the company’s ongoing rolling New Drug Application with the U.S. Food and Drug Administration (FDA).
The 26-week analysis included nearly 600 patients with chronic TRD, whose current depressive episodes had lasted more than three years on average and who had experienced more than six lifetime depressive episodes.
Among patients receiving two fixed 25 mg doses of COMP360, 39% achieved at least a 25% reduction in their Montgomery-Åsberg Depression Rating Scale (MADRS) score by Week 6, with benefits maintained through at least Week 26.
By comparison, 25% of patients in the earlier COMP005 study achieved the same response after a single dose, suggesting a second dose may provide additional clinical benefit for some patients.
Safety Findings Remain Consistent
