SAN DIEGO, Aug. 13, 2015
/PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
announced today that it has recently completed subject
randomization of the Phase III clinical trial
(Kinect 3 Study) of its proprietary Vesicular Mono-Amine
Transporter 2 (VMAT2) compound NBI-98854 in tardive
dyskinesia patients.
The design of the Kinect 3 Study is a randomized,
parallel-group, double-blind, placebo-controlled trial of
approximately 240 subjects with moderate to severe tardive
dyskinesia and an underlying diagnosis of mood disorder,
schizophrenia or schizoaffective disorder. The initial six
weeks of treatment consists of an efficacy and safety assessment of
80mg and 40mg once-daily NBI-98854 against placebo. This will
be followed by an additional 42 weeks of long-term safety
assessment where all subjects are randomized in a blinded fashion
to either 80mg or 40mg once-daily NBI-98854. Topline efficacy
data from the initial six week assessment is expected in the fourth
quarter of 2015.
"Completing enrollment of the Kinect 3 study is another
milestone in the development of NBI-98854 and we look forward to
sharing the top-line results next quarter," said Christopher F. O'Brien, Chief Medical Officer of
Neurocrine Biosciences.
Kinect 3 Study Design
The Kinect 3 study is a randomized, parallel-group,
double-blind, placebo-controlled, Phase III clinical trial
utilizing the capsule formulation of NBI-98854 in moderate to
severe tardive dyskinesia patients with underlying schizophrenia,
schizoaffective disorder or mood disorder (including bipolar
disorder or major depressive disorder). The primary endpoint
in the Kinect 3 study is the mean change from baseline in the
Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded
central raters. The Kinect 3 study will include approximately
240 subjects randomized to either placebo, once daily 40mg of
NBI-98854 or once daily 80mg of NBI-98854
for six weeks. Subsequent to the completion of the
six week placebo-controlled dosing, all subjects will continue
on once daily 40mg or once daily 80mg of NBI-98854 through
Week 48.
The Kinect 3 study, along with the previous efficacy studies of
NBI-98854, is designed to complete the placebo-controlled clinical
efficacy evaluation of NBI-98854 in tardive dyskinesia. In
addition to this tardive dyskinesia study, a separate one-year
open-label safety study of NBI-98854, Kinect 4, has also been
initiated to support the anticipated 2016 filing of a New Drug
Application in tardive dyskinesia.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the extremities: lip smacking, grimacing, tongue
protrusion, facial movements or blinking, puckering and pursing of
the lips, or involuntary movements of the limbs. These
symptoms are rarely reversible and there are currently no approved
treatments.
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.
As announced previously, Neurocrine has also received
Breakthrough Therapy Designation from the FDA for NBI-98854 in the
treatment of tardive dyskinesia.
The Company is also exploring NBI-98854 in an initial Tourette
syndrome clinical trial, the T-Force study. This study is an
open-label, multi-dose, two-week evaluation of 36 subjects with
Tourette syndrome. Children and adolescents enrolled in the trial
are receiving a once-daily dose of NBI-98854 during a two-week
treatment period to assess both the safety and tolerability of
NBI-98854. Additionally, the Yale Global Tic Severity Scale and the
Premonitory Urge for Tics Scale are being utilized during the study
to assess the impact of NBI-98854 on the patients' Tourette
symptoms. Data read out from the T-Force study is expected in the
fourth quarter of 2015.
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-99854 development.
Specifically, the risks and uncertainties the Company faces
include risks that NBI-99854 clinical development activities may
not be completed on time or at all; risks that NBI-99854 clinical
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-99854 is safe and
effective, or may not be predictive of real-world results or of
results in subsequent clinical trials; risks that NBI-99854
regulatory submissions may not occur or be submitted in a timely
manner; risks that NBI-99854 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-99854; risks that NBI-99854 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-99854; risks that the Company will be unable to raise
additional funding, if required, to complete development of
NBI-99854; risk and uncertainties relating to competitive products
and technological changes that may limit demand for NBI-99854; 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.