SAN DIEGO, May 23, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that the initial
Phase II Tourette syndrome T-Force GREEN study of
INGREZZA®(valbenazine), a small molecule VMAT2
inhibitor, did not meet its primary endpoint. The pre-specified
primary endpoint was the change-from-baseline between the placebo
and active groups in the Yale Global Tic Severity Scale (YGTSS) at
Week 6 in the intent-to-treat (ITT) population.
Exposure-response analysis showed that the selected doses for
this placebo-controlled Phase II study were below the therapeutic
range for adequate tic reduction in the majority of pediatric
subjects. For the subset of subjects with pharmaceutical exposure
in the appropriate range, there was a substantial reduction in tics
(e.g., -11.3 to -13.7 points on the YGTSS). For subjects with
sub-therapeutic exposure, tic reduction was comparable to placebo
(e.g., -4.7 to -8.3 points on the YGTSS). In this study,
adverse events were consistent with those observed in previous
INGREZZA studies. There were a total of four discontinuations
due to adverse events, two in each of the placebo and INGREZZA
arms.
"This study showed that we underestimated the INGREZZA dose
needed for the pediatric population but also provided us with a
clear-cut view into the level of dosing required for future
studies," said Christopher F.
O'Brien, Chief Medical Officer of Neurocrine. "We have
developed a complete exposure-response model from this study that
we believe accurately defines the appropriate dose-range to be
tested in the next clinical study that will be started later this
year. We were very pleased with the conduct of the T-Force
GREEN study in that we were able to identify the appropriate
pediatric subjects for the clinical trial, and the investigators
demonstrated consistent and appropriate application of the Yale
Global Tic Severity Scale."
About T-Force GREEN
The T-Force GREEN study was a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, Phase II study of
98 children and adolescents. Pediatric Tourette syndrome patients
received once-daily dosing of INGREZZA or placebo during a six-week
treatment period to assess the safety, tolerability and efficacy of
INGREZZA. The primary endpoint of this study was the
change-from-baseline of the Yale Global Tic Severity Scale between
placebo and active treatment groups at the end of week six. The
study assessed two doses of INGREZZA for each of the child and
adolescent study arms.
Additionally, the Company is also conducting an open-label,
fixed-dose study of INGREZZA in up to 180 subjects with Tourette
syndrome. This study has recently completed enrollment and was
designed to enroll up to 90 children and adolescents and up to 90
adults who have completed either of the two placebo-controlled
Tourette syndrome clinical trials: T-Force GREEN or T-Forward. This
Phase II study will assess the long-term safety and tolerability of
INGREZZA in children and adults with Tourette syndrome.
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.
About INGREZZA
INGREZZA, a selective VMAT2 inhibitor, is the first and only
product approved for the treatment of adults with tardive
dyskinesia (TD). INGREZZA inhibits VMAT2 and is thought to work by
reducing the amount of dopamine released in a region of the brain
that controls movement and motor function, helping to regulate
nerve signaling in adults with TD. VMAT2 is a protein in the brain
that packages neurotransmitters, such as dopamine, for transport
and release in presynaptic neurons. INGREZZA, developed in
Neurocrine's laboratories, is novel in that it selectively inhibits
VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic
(including D2), serotonergic, adrenergic, histaminergic, or
muscarinic receptors. Additionally, INGREZZA can be taken
once-daily, and together with psychiatric medications such as
antipsychotics or antidepressants.
Conference Call and Webcast Today at 5:00PM Eastern Time
Neurocrine will hold a live conference call and webcast today at
5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access
the live conference call by dialing 877-876-9170 (US) or
785-424-1672 (International) using the conference ID: NBIX. The
call can also be accessed via the webcast through the Company's
website at http://www.neurocrine.com.
About Neurocrine Biosciences
Neurocrine Biosciences is a San
Diego based biotechnology company focused on neurologic,
psychiatric and endocrine related disorders. In April of 2017, the
FDA approved INGREZZA (valbenazine) capsules for the treatment of
adults with tardive dyskinesia (TD). INGREZZA is a novel,
selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and
is the first and only FDA-approved product indicated for the
treatment of adults with TD. The Company markets INGREZZA in
the United States. The Company's
three late-stage clinical programs are: elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc.; opicapone, a novel, once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
inhibitor under investigation as adjunct therapy to levodopa in
Parkinson's patients; and INGREZZA (valbenazine), a novel,
once-daily, selective VMAT2 inhibitor under investigation for the
treatment of Tourette syndrome.
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 INGREZZA (valbenazine)
development for Tourette syndrome. Specifically, the risks and
uncertainties the Company faces include risks that INGREZZA
development activities may not be completed on time or at all;
risks that INGREZZA development activities may not be completed or
may be delayed for regulatory or other reasons, may not be
successful or replicate previous clinical trial results, may fail
to demonstrate that INGREZZA is safe, tolerable or effective in the
Tourette syndrome population, 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; risks that INGREZZA may
not obtain regulatory approval for Tourette syndrome, or that the
U.S. Food and Drug Administration or regulatory authorities outside
the U.S. may make adverse decisions regarding INGREZZA; 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 and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA; and other risks
described in the Company's quarterly report on Form 10-Q for the
quarter ended March 31, 2017.
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.