SAN DIEGO, Nov. 4, 2015
/PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a
biotechnology company focused on neurological and endocrine related
disorders, announced today that the Company's Investigational New
Drug (IND) application, filed with the U.S. Food and Drug
Administration, for NBI-640756 for patients with essential tremor
is now active. NBI-640756 was discovered in the Neurocrine
laboratories and the Company has initiated a sequential
dose-escalation Phase I safety and pharmacokinetics study exploring
NBI-640756 in healthy volunteers, with top-line data expected the
first-half of next year.
"Neurocrine's research team has added another facet to our
growing franchise in movement disorders by discovering a novel
compound that shows great promise in preclinical models of
essential tremor," said Kevin C.
Gorman, President and Chief Executive Officer of Neurocrine
Biosciences. "A successful readout from this initial Phase I study
will lead to the initiation of a multiple ascending dose study of
NBI-640756 next year."
Phase I Study Design
This Phase I study is a single site, randomized, double-blind,
placebo-controlled, sequential dose-escalation, pharmacokinetic
study assessing the safety and tolerability of a single
dose of NBI-640756 in up to 32 healthy volunteers. The study will
be conducted in multiple sequential cohorts of eight subjects per
cohort.
About Essential Tremor
Essential tremor is one of the most common neurological
disorders in adults, impacting an estimated 10 million Americans
(International Essential Tremor Foundation). The disorder is
characterized by involuntary, rhythmic, oscillatory movements that
most often affect the upper limbs. As the disease progresses,
tremor severity often increases and spreads to other parts of the
body. Essential tremor has a significant impact on the activities
of daily living often resulting in functional disability as the
disease progresses and is associated with a high comorbidity rate
of social phobia, depression and anxiety. Current pharmacological
therapies utilized in the treatment of essential tremor include
propranolol and primidone. Deep brain stimulation, an invasive
procedure involving the implantation of electrodes within certain
areas of the brain, is sometimes utilized for severe essential
tremor.
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 business and finances in general, as well as
risks and uncertainties associated with the Company's essential
tremor program and Company overall. Specifically, the risks and
uncertainties the Company faces with respect to the Company's
essential tremor program include, but are not limited to: risk that
NBI-640756 will not proceed to later stage clinical trials and risk
that the Company's clinical trials will fail to demonstrate that
NBI-640756 is safe and/or effective; risks that NBI-640756 may
cause unanticipated adverse effects, in the current study or
subsequent clinical trials; risks that development activities may
not be completed on time or at all; risks that clinical development
activities may be delayed or discontinued for regulatory or other
reasons, may not be successful or replicate pre-clinical 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; or the risk that
NBI-640756 may not obtain regulatory approval. With respect
to its pipeline overall, the Company faces risk relating to the
Company's dependence on contract manufacturers for clinical drug
supply; 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; risks
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 overall risks associated with
the process of discovering, developing and commercializing drug
candidates that are safe and effective for use as human
therapeutics and the other risks described in the Company's report
on Form 10-Q for the quarter ended September
30, 2015. Neurocrine disclaims any obligation to update the
statements contained in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.