GH Research (GHRS) PLC reported the primary endpoint was met in a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001, an inhalable mebufotenin product candidate, in patients with treatment-resistant depression. GH001 led to a significant reduction from baseline of -15.2 points in Montgomery-Asberg Depression Rating Scale total score on Day 8, compared with +0.3 points in the placebo group. All secondary endpoints in the trial were met, with results consistent with the primary endpoint. Treatment with GH001 led to clinically and statistically significant improvements on the CGI-S and HAM-A scales and the Q-LES-Q-SF Questionnaire on Day 8, compared with placebo.
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