Neurocrine Biosciences (NBIX) Announces Positive Data From Phase II Trial of Elagolix
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After the close, Neurocrine Biosciences, Inc. (Nasdaq: NBIX) 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 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%).
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