September 4, 2008
Neurocrine Reports Positive Results From Phase II Endometriosis Trial
Neurocrine Biosciences, a biopharmaceutical company, has announced positive safety and efficacy results from its third Phase II clinical trial using its proprietary, orally-active nonpeptide gonadotropin-releasing hormone receptor antagonist, elagolix, in patients with endometriosis.
The Petal study enrolled 252 patients, with a confirmed diagnosis of endometriosis, into three treatment groups - elagolix 150mg once daily, elagolix 75mg twice daily, or depo-subQ provera 104 (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 six 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 six, the lower bound of the 95% confidence interval did not exceed a -2.2% change in BMD from baseline.
In women randomized to elagolix 150mg once daily, the mean percent change from baseline at month six 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 six for the elagolix 75mg twice daily dosing arm was -1.30% for the spine (lower bound -1.86%) and -0.99% for the femur (lower bound -1.46%).
Secondary endpoints for the Petal study were evaluated to assess the improvement of endometriosis symptoms following treatment with elagolix. Improvement in endometriosis symptoms was documented using several different scales for endometriosis pain. Treatment with elagolix was also safe and generally well tolerated.
Kevin Gorman, president and CEO of Neurocrine Biosciences, said: "We began this program nine years ago with the hope of selectively modulating the gonadotropin-releasing hormone receptor system with an oral antagonist. This trial and our previous Phase II studies have now shown that this is possible. Elagolix is a first in class drug for endometriosis sufferers who desperately need a safe and effective therapy."