Neurocrine Biosciences Announces Successful Elagolix PETAL Study in End...( Phase II Study Meets Primary Bone M...),Health

Phase II Study Meets Primary Bone Mineral Density and Secondary Efficacy

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SAN DIEGO, Sept. 2 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive safety and efficacy results from its third Phase II clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. The PETAL study enrolled 252 patients, with a confirmed diagnosis of endometriosis, into three treatment groups; elagolix 150 mg once daily, elagolix 75 mg twice daily, or depo-subQ provera 104(TM) (DMPA) for six months of treatment.

The primary endpoint for the PETAL study was the percent change from baseline in mean bone mineral density (BMD) at Month 6 measured via dual energy X-ray absorptiometry (DXA). Pursuant to discussion with the FDA, the pre-specified statistical analysis plan sought to demonstrate that at Month 6, the lower bound of the 95% confidence interval did not exceed a -2.2% change in BMD from baseline. In women randomized to elagolix 150 mg once daily, the mean percent change from baseline at Month 6 was -0.11% for the spine (lower bound -0.70%) and -0.47% for the femur (lower bound -0.96%). The mean percent change from baseline at Month 6 for the elagolix 75 mg twice daily dosing arm was -1.30% for the spine (lower bound -1.86%) and -0.99% for the femur (lower bound -1.46%).

"The PETAL study demonstrates that elagolix did not induce significant bone loss over a six month treatment of patients with endometriosis, while providing both rap
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