The company said, "We are pleased to report that we have recently initiated our multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression. GH001 is our proprietary inhalable mebufotenin product candidate. We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective will be to determine the efficacy of our single-day individualized dosing regimen of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Asberg Depression Rating Scale at the end of the 7-day double-blind phase. The double-blind phase will be followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status."
Published first on TheFly
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