SAN DIEGO, Jan. 17, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today the top-line
results from the Company's Phase II T-Forward study of
INGREZZA™ (valbenazine), a highly-selective small
molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in
adults with Tourette syndrome. While the study showed a significant
improvement in overall symptoms of Tourette syndrome as evidenced
by the Clinical Global Impression of Change (p=0.015), the
pre-specified primary endpoint, the change-from-baseline in the
Yale Global Tic Severity Scale (YGTSS) at Week 8 was not met
(p=0.18). Adverse events were dose dependent and consistent with
earlier clinical studies.
"Overall we were very pleased with the conduct of the study,
including the investigators' administration of the Yale Global Tic
Severity Scale as well as the safety profile of INGREZZA in adults
with Tourette syndrome," said Chris
O'Brien, Chief Medical Officer of Neurocrine. "Through this
initial placebo-controlled study we gained valuable insights into
the conduct of clinical trials in Tourette patients, including
patient identification methods and appropriate study
inclusion/exclusion criteria. As we have done with our previous
early Phase II studies in both endometriosis and tardive
dyskinesia, we will apply these new insights to future Tourette
studies."
"This T-Forward study has provided us with our first experience
in applying the Yale Global Tic Severity Scale with adult patients
in a placebo-controlled setting. We are pleased with the clinical
response observed across the various efficacy assessments," said
Kevin Gorman, Chief Executive
Officer of Neurocrine. "At present, we are not disclosing specific
details of this study in order to avoid the potential introduction
of assessment bias in the ongoing Phase II T-Force GREEN study of
pediatric Tourette patients. We look forward to the pediatric study
readout next quarter and our subsequent discussion with the FDA on
our plans for Phase III development of INGREZZA in Tourette
syndrome."
T-Forward Study Design
The T-Forward study was a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, Phase II study to
evaluate the safety, tolerability and efficacy of valbenazine in
adults with moderate to severe Tourette syndrome. Two once-daily
fixed doses of valbenazine were evaluated vs. placebo in a 1:1:1
randomization. The three-arm study evaluated 124 patients over
eight weeks of dosing followed by two weeks off-drug at 32
study centers in the United
States. The primary endpoint of this study was a change from
baseline of placebo vs. active scores utilizing the YGTSS at
the end of Week 8. Tourette symptoms were also evaluated via the
Premonitory Urge for Tics Scale as well as the Clinical Global
Impression of Change scale, among others.
Conference Call and Webcast at 4:30pm
Eastern Time
Neurocrine will host a live conference call and webcast to
discuss this press release today at 4:30pm
Eastern Standard Time (EST)/ 1:30pm
Pacific Standard Time (PST). Participants may access the
live conference call by dialing 888-632-3381 (US) or 785-424-1678
(International) and using the conference ID NBIX. The call can also
be accessed via the Webcast through Neurocrine's website at
http://www.neurocrine.com.
If you are unable to attend the webcast a replay of the
conference call will be available approximately one hour after the
conclusion of the call by dialing 800-839-1180 (US) or 402-220-0400
(International) using the conference ID NBIX. The call will be
archived for one month.
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 INGREZZA
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. INGREZZA (valbenazine or NBI-98854),
developed in the Neurocrine laboratories, is a novel,
highly-selective VMAT2 inhibitor that modulates dopamine release
during nerve communication, showing little or no affinity for
VMAT1, other receptors, transporters and ion channels. INGREZZA is
designed to provide low, sustained, plasma and brain concentrations
of active drug to allow for once daily dosing. The proprietary name
INGREZZA has been conditionally accepted by the U.S. Food and Drug
Administration (FDA).
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, may provide symptomatic
benefits for patients with these diseases.
The Company has a pending New Drug Application (NDA) under
review by the FDA to utilize INGREZZA for the treatment of tardive
dyskinesia. The Company also has another ongoing placebo-controlled
Phase II Tourette syndrome study evaluating INGREZZA in pediatrics,
the T-Force GREEN study. Additionally, the Company has an ongoing
open-label, fixed-dose rollover study of INGREZZA in up to 180
subjects with Tourette syndrome.
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 INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement disorders.
Neurocrine plans to commercialize INGREZZA in the United States upon approval by the
FDA.
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 contains
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 INGREZZA development for both tardive
dyskinesia and/or Tourette syndrome. Specifically, the risks and
uncertainties the Company faces include risks that the INGREZZA NDA
may not obtain regulatory approval from the FDA for tardive
dyskinesia or such approval may be delayed or conditioned; risks
that additional regulatory submissions, for Tourette syndrome or
otherwise, may not occur or be submitted in a timely manner; risks
that the FDA or regulatory authorities outside the U.S. may make
adverse decisions regarding INGREZZA; risks that INGREZZA
development activities for Tourette syndrome may not be completed
on time or at all; risks that ongoing INGREZZA development
activities may be delayed for regulatory or other reasons; risks
that ongoing or future INGREZZA clinical trials may not be
successful or replicate previous clinical trial results, may fail
to demonstrate that INGREZZA is safe, tolerable or effective, or
may not be predictive of real-world results or of results in
subsequent clinical trials; risks that INGREZZA 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
INGREZZA; risks that the Company will be unable to raise additional
funding, if required, to complete development of or commercialize
INGREZZA; risks and uncertainties relating to competitive products
and technological changes that may limit demand for INGREZZA; and
other risks described in the Company's annual report on Form 10-Q
for the quarter ended September 30,
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.