Neurocrine Biosciences has announced positive results of its proof of concept, safety, efficacy and dose-finding Phase II clinical trial using its proprietary, orally-active small molecule gonadotropin-releasing hormone receptor antagonist NBI-56418.
The three-month data comes from a multicenter, randomized, double-blind, placebo-controlled trial involving patients with a confirmed diagnosis of endometriosis. The study followed a parallel-group design in which 76 subjects were randomized to one of three treatment groups: placebo, 75 mg of NBI-56418, or 150 mg of NBI-56418, each administered once daily. Dosing started on Day 2 to Day 7 of the menstrual cycle and continued over 12 weeks.
Full data regarding treatment impact on menses, hormones and a variety of metabolic biomarkers will be available at the completion of the ongoing three-month safety follow-up period.