STUDY TO ASSESS IMPACT OF ELAGOLIX ON BONE MINERAL DENSITY
SAN DIEGO, June 17 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc.
(Nasdaq: NBIX) 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.
SOURCE Neurocrine Biosciences, Inc.
CONTACT: Claudia Woodworth of Neurocrine Biosciences, Inc.,
+1-858-617-7600
Web site: http://www.neurocrine.com