NEUROCRINE REPORTS POSITIVE RESULTS FROM ENDOMETRIOSIS STUDY

Neurocrine Biosciences announced positive preliminary results from its second proof-of-concept, safety and efficacy Phase II clinical trial over a three-month treatment period using its proprietary, orally active nonpeptide Gonadotropin-Releasing Hormone receptor antagonist (NBI-56418) in patients with endometriosis.

The 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 68 subjects were randomized to one of three treatment groups: placebo, 50 mg of NBI-56418 or 100 mg of NBI-56418, each administered twice daily.

Dosing started on day two to day seven of the menstrual cycle and continued over 12 weeks with assessments of symptoms and signs of disease conducted at four-week intervals using the Composite Pelvic Sign and Symptoms Score (CPSSS) for the primary endpoint of reduction in endometriosis symptoms. In addition, assessment of pain intensity was measured daily by a Visual Analog Scale (VAS) and collected by electronic diary. Full data regarding treatment impact on menses and a variety of biomarkers will be available at the completion of the ongoing three-month safety follow-up period.

For the primary endpoint of CPSSS, which has a maximum possible value of 15, mean values at baseline were 7.8, 7.2 and 8.3 for the placebo, 50- and 100-mg groups, respectively. After treatment, there were reductions of 4.3 (placebo), 4.7 (50 mg) and 5.3 (100 mg) points in the score at week 12. The dysmennorrhea component of the scale showed the most consistent dose-related reductions of 0.9, 1.3 and 1.9 points, and dysmenorrhea was absent at 12 weeks in 81 percent of women randomized to the 100-mg group compared with 17 percent of the placebo recipients. The VAS data reveal dose-related improvements in "worst pain" (maximum score), particularly at week four, with reductions of 3 (placebo), 17 (50 mg) and 20 (100 mg) from the screening period maximum VAS means of 73, 68 and 72, respectively.