NEUROCRINE RELEASES DATA FROM PHASE II ENDOMETRIOSIS STUDY
Neurocrine Biosciences has announced positive safety and efficacy results from review of the second off-treatment three-month period of its six-month, proof-of-concept, safety, efficacy and dose-finding Phase II clinical trial using its proprietary, orally active, small-molecule gonadotropin-releasing hormone (GnRH) receptor antagonist (NBI-56418).
The six-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 administered once daily. Patients were followed for three months on active treatment or placebo and for an additional post-treatment three-month period to assess safety.
While the primary endpoint of the study, reduction in the Composite Pelvic Sign and Symptoms Score, showed a greater than 5 point reduction in the higher dose group (150 mg), most striking was the reduction in the worst pain as measured by the Visual Analog Scale. The mean maximum score reported in the pre-treatment phase ranged 63 to 73. These were reduced by an average of 13.1 (placebo), 25.8 (75 mg) and 37.4 (150 mg) during the third month on treatment. Pain reduction was reported within the first few weeks of treatment by some patients, and benefits were sustained for up to 12 weeks after discontinuation in many patients. Complete suppression of menses was only seen in a small subset of subjects.
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