SAN DIEGO, Oct. 20, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that it has
expanded the clinical efforts for NBI-98854 (Valbenazine), a highly
selective small molecule Vesicular Monoamine Transporter 2 (VMAT2)
inhibitor, by initiating a Phase II clinical trial in adults with
Tourette syndrome.
The T-Forward study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, study of up to 90
adults. Subjects will receive once-daily dosing of NBI-98854 during
an eight-week treatment period to assess the safety, tolerability
and efficacy of NBI-98854 in Tourette patients. The primary
endpoint of this study is a change from baseline of placebo vs.
active scores utilizing the Yale Global Tic Severity Scale at the
end of Week 8. Data readout from this study is expected later in
2016.
"Evaluation of Valbenazine in adults with Tourette syndrome is
another important step in fully exploring its potential in movement
disorders," said Christopher F.
O'Brien, Chief Medical Officer of Neurocrine Biosciences.
"We look forward to our T-Force study readout of children and
adolescents with Tourette's during this quarter, and our
anticipated NDA filing of NBI-98854 for tardive dyskinesia in
2016."
T-Forward Study Design
The T-Forward study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, Phase II study to
evaluate the safety, tolerability and efficacy of NBI-98854 in
adults with moderate to severe Tourette syndrome. Two once-daily
fixed doses of NBI-98854 will be evaluated vs. placebo in a 1:1:1
randomization. The three-arm study will evaluate up to 90 patients
over eight weeks of dosing followed by two weeks off-drug at
approximately 40 study centers in the
United States. The primary endpoint of this study is a
change from baseline of placebo vs. active scores utilizing the
Yale Global Tic Severity Scale at the end of Week 8. Tourette
symptoms will also be evaluated via the Premonitory Urge for Tics
Scale as well as Clinical Global Impression of Change scales, among
others.
About Tourette Syndrome
Tourette syndrome is a neurological disorder that consists of
rapid, non-rhythmic stereotyped motor and vocal tics. Motor tics
are typically characterized by facial grimacing, head jerks,
extremity movements and other dystonic movements. Vocal tics
typically include grunting, throat clearing, and repeating words
and phrases. The average age at onset for Tourette syndrome is at
six years, with symptoms reaching their peak severity at
approximately age ten. Tourette syndrome is more commonly diagnosed
in males than females and may be associated with attention deficit
hyperactivity disorder and obsessive compulsive disorder. There are
approximately 400,000 people with Tourette syndrome in the United States.
About NBI-98854
VMAT2 is a protein concentrated in the human brain that is
primarily responsible for re-packaging and transporting monoamines
(dopamine, norepinephrine, serotonin, and histamine) in
pre-synaptic neurons. NBI-98854, developed in the Neurocrine
laboratories, is a novel, highly-selective VMAT2 inhibitor that
modulates dopamine release during nerve communication, while at the
same time having minimal impact on the other monoamines, thereby
reducing the likelihood of "off-target" side effects. NBI-98854 is
designed to provide low, sustained, plasma and brain concentrations
of active drug to minimize side effects associated with excessive
monoamine depletion.
Modulation of neuronal dopamine levels in diseases such as
tardive dyskinesia, Tourette syndrome, Huntington's chorea,
schizophrenia, and tardive dystonia, which are characterized, in
part, by a hyperdopaminergic state, should provide symptomatic
benefits for patients with these diseases.
The Company has two distinct Investigational New Drug
Applications related to NBI-98854, tardive dyskinesia and Tourette
syndrome, open with the Division of Psychiatry Products at the FDA.
Neurocrine has received Breakthrough Therapy Designation from the
FDA for NBI-98854 in the treatment of tardive dyskinesia and
expects to file a New Drug Application for tardive dyskinesia in
2016.
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 NBI-98854 development.
Specifically, the risks and uncertainties the Company faces include
risks that NBI-98854 development activities may not be completed on
time or at all; risks that NBI-98854 development activities may be
delayed for regulatory or other reasons, may not be successful or
replicate previous clinical trial results, may fail to demonstrate
that NBI-98854 is safe and effective, or may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that NBI-98854 regulatory submissions may not occur or be
submitted in a timely manner; risks that NBI-98854 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 NBI-98854; risks that NBI-98854 may be
precluded from commercialization by the proprietary rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks associated with the Company's dependence
on third parties for development and manufacturing activities
related to NBI-98854; risks that the Company will be unable to
raise additional funding, if required, to complete development of
NBI-98854; risks and uncertainties relating to competitive products
and technological changes that may limit demand for NBI-98854; and
other risks described in the Company's quarterly report on Form
10-Q for the quarter ended June 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.