SAN DIEGO, June 17 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. announced today that the elagolix 0603 Phase IIb trial (Petal Study) has completed the 6-month treatment phase. The last subject completed her Week 24 study visit in early June. This Phase IIb trial assesses the impact of elagolix treatment on bone mineral density (BMD) as the primary endpoint using Dual Energy X-ray Absorptiometry (DXA) scans to document any change from baseline. In addition, efficacy assessments of endometriosis symptoms using the Composite Pelvic Sign and Symptoms Score (CPSSS) and Visual Analog Scale (VAS) are secondary endpoints.
“The Petal Study is an important trial for the elagolix program,” says Christopher O’Brien, MD, Chief Medical Officer and Senior Vice President of Clinical Development. “For the first time we have the opportunity to examine the relationship between estradiol, n-telopeptide (a biomarker for bone resorption), elagolix plasma concentrations and BMD using DXA. We included a positive control, Depo-Provera, as one treatment arm in this randomized, double-blind, active comparator controlled trial to provide confidence that the trial would not miss subtle treatment-related effects,” stated Dr. O’Brien.
“The recruitment process for the Petal Study confirms that endometriosis is an important, unmet medical need afflicting many women in the United States. Our call center received over 8,000 calls expressing interest in new treatments for endometriosis,” reports Dr. O’Brien. A total of 252 women with endometriosis were randomized to one of three treatment arms: oral elagolix 150mg once daily, oral elagolix 75mg twice daily or Depo-Provera injection every 3 months. After completing the 6-month treatment phase, subjects continue in the blinded trial for additional DXA, safety and clinical evaluations at 6 and 12 months post treatment per Food and Drug Administration (FDA) recommendations. The collection of treatment phase data, quality control processing and statistical analyses will take place over the upcoming weeks. As announced previously, Neurocrine is on track to report this treatment phase topline data in early September 2008.
The Petal Study will contribute to the extensive data set of 10 Phase I studies, 2 Phase IIa studies and 3 Phase IIb studies that will serve as the basis for end-of-phase II discussions anticipated in 2009 with the Division of Reproductive and Urologic Drug Products at the FDA.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, irritable bowel syndrome (IBS), anxiety, depression, pain, diabetes, benign prostatic hyperplasia (BPH) and other neurological and endocrine related diseases and disorders. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s business and finances in general, as well as risks and uncertainties associated with the Company’s GnRH program and R & D pipeline and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company’s GnRH program include, but are not limited to, risk that the Company’s elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Company’s dependence on corporate collaborators for development, commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2007 and on Form 10-Q for the period ended March 31, 2008. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
CONTACT: Claudia Woodworth of Neurocrine Biosciences, Inc.,
+1-858-617-7600
Web site: http://www.neurocrine.com/
