SAN DIEGO, Feb. 2, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that it has
initiated a Phase II clinical trial for NBI-98854 (valbenazine), a
highly selective small molecule Vesicular Monoamine Transporter 2
(VMAT2) inhibitor, in children and adolescents with Tourette
syndrome.
The T-Force GREEN study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, study of up to 90
children and adolescents. Subjects will receive once-daily dosing
of valbenazine during a six-week treatment period to assess the
safety, tolerability and efficacy of valbenazine in pediatric
Tourette patients. The primary endpoint of this study is the change
from baseline of the Yale Global Tic Severity Scale between placebo
and active treatment groups at the end of week six. Data readout
from this study is expected later in 2016.
"Following the favorable results from our two-week T-Force study
of valbenazine in pediatric Tourette patients, we are launching the
T-Force GREEN study assessing children and adolescents over six
weeks of continuous dosing," said Christopher F. O'Brien, Chief Medical Officer of
Neurocrine Biosciences. "This study, coupled with the ongoing
T-Forward study of adults with Tourette syndrome, will elucidate
trial design, efficacy and safety outcomes for discussion with
regulatory authorities on the utilization of valbenazine in
Tourette syndrome. Additionally, the ongoing Kinect studies of
valbenazine in patients with tardive dyskinesia will support our
anticipated NDA filing of valbenazine for tardive dyskinesia later
this year."
T-Force GREEN Study Design
The T-Force GREEN study is a multicenter, randomized,
double-blind, placebo-controlled, multi-dose, parallel group, Phase
II study to evaluate the safety, tolerability and efficacy of
NBI-98854 in up to 90 pediatric patients 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 45 children and 45 adolescents over six 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 the change from
baseline of the Yale Global Tic Severity Scale between placebo and
active treatment groups at the end of week six. Tourette symptoms
will also be evaluated via the Rush Video-Based Tic Rating Scale,
Premonitory Urge for Tics Scale as well as Clinical Global
Impression 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 Valbenazine
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. Valbenazine (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. Valbenazine 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.
Neurocrine has received Breakthrough Therapy Designation from
the FDA for valbenazine 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 valbenazine, 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 (valbenazine)
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 September 30, 2015. Neurocrine disclaims any
obligation to update the statements contained in this press release
after the date hereof.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-announces-initiation-of-phase-ii-clinical-study-of-vmat2-inhibitor-valbenazine-in-children-and-adolescents-with-tourette-syndrome-300213365.html
SOURCE Neurocrine Biosciences, Inc.