SAN DIEGO, July 28, 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, adolescents and adults with
Tourette syndrome.
This study is an open-label, fixed-dose, study of up to 180 male
and female patients with Tourette syndrome, consisting of up to 90
children and adolescents and up to 90 adults. The primary purpose
of the study is to assess the long-term safety and tolerability of
valbenazine. Enrollment in this long-term study is limited to
subjects who have completed either the ongoing placebo-controlled
T-Force GREEN or T-Forward studies. Patients will receive
once-daily dosing during a twenty-four week treatment period to
assess the safety and tolerability of valbenazine.
"We are very pleased with the conduct of our two ongoing
placebo-controlled Phase II studies in Tourette syndrome. The
clinical sites are successfully reaching out to patients and
families for enrollment and the subject characteristics are exactly
in line with our expectations," said Christopher F. O'Brien, Chief Medical Officer of
Neurocrine Biosciences. "This six-month extension study provides us
with necessary longer-term exposure of valbenazine in both children
and adults with Tourette syndrome and will assist in designing our
planned Phase III program."
Long-Term Phase II Study Design
The study is an open-label, fixed-dose, Phase II study to
evaluate the safety and tolerability of NBI-98854 in up to 180
patients with Tourette syndrome. The study will enroll up to 90
pediatric patients and 90 adult patients with moderate to severe
Tourette syndrome. Enrollment in this study is restricted to
subjects who have completed either the T-Force GREEN or T-Forward
Phase II studies. Evaluation of subjects in the study consists of
up to three weeks of screening followed by twenty-four weeks of
dosing, then followed by four weeks off-drug at approximately 60
study centers in the United States. Once-daily fixed
doses of valbenazine will be evaluated for safety and tolerability
via standard clinical laboratory tests, monthly physician
examinations and safety scale assessments. The dosing regimen for
this study is consistent with the two ongoing Phase II studies;
T-Force GREEN and T-Forward. During the study, the symptoms of
Tourette syndrome will be evaluated utilizing the Yale Global Tic
Severity Scale, the Rush Video-Based Tic Rating Scale, Premonitory
Urge for Tics Scale as well as Clinical Global Impression
scales.
About T-Force GREEN and T-Forward Studies
The T-Force GREEN and T-Forward studies are ongoing multicenter,
randomized, double-blind, placebo-controlled, multi-dose, parallel
group, Phase II studies to evaluate the safety, tolerability and
efficacy of valbenazine. Once-daily fixed doses of NBI-98854 are
being evaluated vs. placebo in a 1:1:1 randomization. These studies
will each enroll up to 90 patients with moderate to severe Tourette
syndrome, the T-Force GREEN is enrolling children and adolescents
and the T-Forward is enrolling adults. The primary endpoint of each
of these studies is the change from baseline of the Yale Global Tic
Severity Scale between placebo and active treatment groups at the
end of placebo-controlled treatment. 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 of onset for Tourette syndrome is 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 valbenazine 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 valbenazine is safe, tolerable or
effective, or may not be predictive of real-world results or of
results in subsequent clinical trials; risks that valbenazine
regulatory submissions may not occur or be submitted in a timely
manner; risks that valbenazine may not obtain
regulatory approval for tardive dyskinesia, Tourette syndrome, or
at all, or that the U.S. Food and Drug Administration or regulatory
authorities outside the U.S. may make adverse decisions regarding
valbenazine ; risks that valbenazine 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
valbenazine; risks that the Company will be unable to raise
additional funding, if required, to complete development of
valbenazine ; risks and uncertainties relating to competitive
products and technological changes that may limit demand for
valbenazine ; and other risks described in the Company's quarterly
report on Form 10-Q for the quarter ended March 31, 2016. 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.