SAN DIEGO, June 8, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that it has
suspended two planned clinical studies of the Company's CRF
antagonist NBI-77860.
"Out of an abundance of caution, we halted the implementation of
these studies and notified the FDA of certain recent preclinical
findings that we had not observed in previous animal studies," said
Chris O'Brien, M.D., Chief Medical
Officer at Neurocrine. "We intend to work closely with the FDA to
elucidate these findings and determine the next steps for NBI-77860
in congenital adrenal hyperplasia."
The two clinical studies that were halted include a single dose
study in adolescent females with classic congenital adrenal
hyperplasia and a multiple dose study in adults with classic
congenital adrenal hyperplasia. The Company had not enrolled any
subjects in either study and accordingly, there have been no
adverse events reported.
The Company has also been informed by the FDA that the NBI-77860
clinical development program would be placed on partial clinical
hold.
About Classic Congenital Adrenal Hyperplasia (CAH)
Classic CAH is a genetic disorder that results in an enzyme
deficiency altering the production of adrenal steroids. Because of
this deficiency, the adrenal glands have little to no cortisol
biosynthesis resulting in a potentially life-threatening condition.
If left untreated, classic CAH can result in salt wasting,
dehydration and eventually death. Even with cortisol replacement,
persistent elevation of ACTH from the pituitary gland results in
excessive androgen levels leading to virilization of females
including precocious puberty, menstrual irregularity, short
stature, hirsutism, acne and fertility problems.
Corticosteroids are the current standard of care for classic CAH
which are used to both correct the endogenous cortisol deficiency
and reduce the excessive ACTH levels and androgen excess. However,
the dose and duration of steroid use required to suppress ACTH is
well above the normal physiological level of cortisol; resulting in
metabolic syndrome, bone loss, growth impairment, and Cushing's
syndrome as common and serious side effects.
Additional information on CAH can be obtained from the National
Institutes of Health http://www.nlm.nih.gov, and patient advocacy
groups such as CARES http://www.caresfoundation.org.
About NBI-77860
NBI‑77860 is a potent, selective non-peptide CRF receptor
antagonist as demonstrated in a range of in vitro/in vivo assays
and human clinical studies. Blockade of CRF receptors at the
pituitary has been shown to decrease the release of ACTH, which in
turn decreases the production of adrenal steroids including
androgens, and potentially the symptoms associated with classic
CAH. Lower ACTH levels would also reduce the amount of exogenous
corticosteroid necessary for classic CAH patients to thrive
avoiding the side-effects currently associated with excessive
steroid therapy.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and NBI-98854, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine intends to maintain certain commercial
rights to its VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company. 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 product candidate NBI-77860 in general, including
the risk that NBI-77860 will not be found to be safe and effective.
Specifically, the risks and uncertainties the Company faces for
NBI-77860 include risks that development activities may not be
completed on time or at all; risks that clinical development
activities may be delayed for regulatory or other reasons, may not
be successful or replicate previous clinical trial results, or may
not be predictive of real-world results or of results in subsequent
clinical trials; risks that regulatory submissions may not occur or
be submitted in a timely manner; risk that NBI-77860 candidates may
not obtain regulatory approval; or that the U.S. Food and Drug
Administration or regulatory authorities outside the U.S. may make
adverse decisions regarding the Company's product candidates; and
the other risks described in the Company's quarterly report on Form
10-Q for the quarter ended March 31,
2015. Neurocrine disclaims any obligation to update the
statements contained in this press release.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-provides-update-on-nbi-77860-program-for-congenital-adrenal-hyperplasia-300095707.html
SOURCE Neurocrine Biosciences, Inc.