Data Presented at the 2023 MDS International
Congress of Parkinson's Disease and Movement
Disorders®
SAN
DIEGO, Aug. 28, 2023 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now
FDA-approved INGREZZA® (valbenazine) capsules for the
treatment of adults with chorea associated with Huntington's disease (HD), including
exploratory results from the Phase 3 KINECT®-HD study,
which showed consistently greater improvements in HD chorea with
INGREZZA versus placebo from Week 2 to Week 12. These data will be
presented at the MDS International Congress of Parkinson's Disease
and Movement Disorders® August
27-31 in Copenhagen,
Denmark.
![(PRNewsfoto/Neurocrine Biosciences, Inc.) (PRNewsfoto/Neurocrine Biosciences, Inc.)](https://mma.prnewswire.com/media/678850/Neurocrine_Biosciences_Logo.jpg)
"The exploratory analysis from our KINECT-HD study further
exemplifies the value of INGREZZA as a now approved medication for
HD chorea with improvements seen with treatment as early as two
weeks," said Eiry W. Roberts, M.D., Chief Medical Officer at
Neurocrine Biosciences. "Additional analyses presented add to the
body of evidence regarding the use of INGREZZA for this patient
population, including an increased understanding of Unified
Huntington's Disease Rating Scale (UHDRS®) Total Maximal
Chorea (TMC) scores that signal clinically meaningful chorea
improvements."
KINECT-HD, a Phase 3, randomized, double-blind,
placebo-controlled study met its primary endpoint of chorea
reduction as assessed using the UHDRS TMC score with a
placebo-adjusted improvement of 3.2 points at Week 12 among those
receiving INGREZZA. Secondary endpoints also demonstrated
significantly greater improvements at Week 12 (ratings of "much
improved" or "very much improved") among those treated with
INGREZZA compared with placebo as assessed using the Clinical
Global Impression of Change (CGI-C; 42.9 percent versus 13.2
percent, respectively) and Patient Global Impression of Change
(PGI-C; 52.7 percent versus 26.4 percent, respectively). These
findings were recently published in The Lancet
Neurology.
The new exploratory analysis of KINECT-HD (Chorea Improvements
Over Time With Once-Daily Valbenazine Treatment In Adults With
Huntington Disease, poster # 879) showed greater placebo-adjusted
improvement in chorea with INGREZZA at the lowest dose (40 mg) as
early as the first treatment visit (Week 2), and greater efficacy
compared to placebo was sustained through Week 12. The
percentage of participants rated "much improved" or "very much
improved" by CGI-C and PGI-C was consistently higher with INGREZZA
than with placebo at all study visits.
"The KINECT-HD study has provided valuable data regarding the
safety and efficacy of INGREZZA for HD chorea in adults, and we
continue to look at the data in new ways," said Erin Furr Stimming, M.D., FAAN, FANA, Principal
Investigator, Huntington Study Group and Professor of Neurology at
McGovern Medical School, UTHealth Houston. "This exploratory
analysis has increased our insight regarding the early and
sustained improvements in chorea severity."
Additional HD chorea presentations at the MDS International
Congress of Parkinson's Disease and Movement Disorders include:
- A Minimal Clinically Important Difference for UHDRS Total
Maximal Chorea Score as a Measure of Chorea Severity in Huntington
Disease (poster # 880)
- Indirect Treatment Comparison of Valbenazine with
Deutetrabenazine for Improvement in Total Maximal Chorea Score in
Huntington Disease (poster # 890)
The full abstracts presented by Neurocrine Biosciences at the
MDS International Congress of Parkinson's Disease and Movement
Disorders are available on the meeting website and can be
accessed by registering.
About Chorea Associated with Huntington's Disease
(HD)
Huntington's disease (HD) is a
hereditary progressive neurodegenerative disorder in which the loss
of certain neurons within the brain causes motor, cognitive and
psychiatric symptoms. Symptoms generally appear between the ages of
30 and 50 years and worsen over a 10- to 25-year period. Most
people with HD experience chorea, an abnormal involuntary movement
disorder, characterized by irregular and unpredictable movements.
Chorea can affect various body parts and interfere with motor
coordination, gait, swallowing and speech. HD is estimated to
affect approximately 41,000 adults in the U.S., with more than
200,000 at risk of inheriting the disease.
About
KINECT®-HD
KINECT®-HD is
a Phase 3, randomized, double-blind, placebo-controlled study
designed to evaluate the efficacy of valbenazine as a once-daily
treatment to reduce chorea associated with Huntington's
disease (HD) and evaluate the safety and tolerability of
valbenazine in patients with HD. The study enrolled 128 adults 18
to 75 years of age who were diagnosed with motor-manifest HD and
who had sufficient chorea symptoms to meet study protocol
criteria.
KINECT-HD used the Unified Huntington's Disease Rating Scale
(UHDRS®) Total Maximal Chorea (TMC) score as the primary
efficacy endpoint. The secondary endpoints included Clinical Global
Impression of Change (CGI-C) response status and Patient Global
Impression of Change (PGI-C) response status for valbenazine
treatment. Treatment with valbenazine resulted in a
placebo-adjusted mean reduction in the TMC score of 3.2 units
(P < 0.0001), indicating a highly statistically
significant improvement in chorea. Secondary endpoints of CGI-C
response status and PGI-C response status were also statistically
significant and supported the improvements in TMC score that were
seen over the 12-week study period.
Treatment-emergent adverse events in this study were generally
consistent with the known safety profile of valbenazine. No
suicidal behavior or worsening of suicidal ideation were observed
in the valbenazine-treated participants in this study.
View the complete study results from the Phase 3 KINECT-HD study
published in The Lancet Neurology online edition. For more
information on the KINECT-HD study, please visit
HuntingtonStudyGroup.org.
About INGREZZA® (valbenazine)
Capsules
INGREZZA is the only one-capsule, once-daily
selective vesicular monoamine transporter 2 (VMAT2) inhibitor
approved by the U.S. Food and Drug Administration for the treatment
of adults with tardive dyskinesia and the treatment of chorea
associated with Huntington's
disease (HD).
INGREZZA, developed by Neurocrine Biosciences, selectively
inhibits VMAT2 with no appreciable binding affinity for VMAT1,
dopaminergic (including D2), serotonergic, adrenergic,
histaminergic or muscarinic receptors. While the specific way
INGREZZA works to treat TD and HD chorea is not fully understood,
INGREZZA selectively targets VMAT2 to inhibit the release of
dopamine, a chemical in the brain that helps control movement.
INGREZZA is believed to reduce extra dopamine signaling, which may
lead to fewer uncontrollable movements. Additionally, INGREZZA can
be taken for the treatment of tardive dyskinesia as one-capsule
once-daily, together with most psychiatric medications such as
antipsychotics or antidepressants. INGREZZA dosages approved for
use are 40 mg, 60 mg and 80 mg capsules. INGREZZA is not approved
in any other dosage form.
Important Information
Approved Uses
INGREZZA® (valbenazine)
capsules is a prescription medicine used to treat adults with:
- movements in the face, tongue, or other body parts that cannot
be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease. INGREZZA does not cure
the cause of involuntary movements, and it does not treat other
symptoms of Huntington's disease,
such as problems with thinking or emotions.
It is not known if INGREZZA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
VMAT2 inhibitors, including INGREZZA, can cause serious side
effects in people with Huntington's disease, including: depression,
suicidal thoughts, or suicidal actions. Tell your
healthcare provider before you start taking INGREZZA if you have
Huntington's disease and are
depressed (have untreated depression or depression that is not well
controlled by medicine) or have suicidal thoughts. Pay close
attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is especially important when
INGREZZA is started and when the dose is changed. Call your
healthcare provider right away if you become depressed, have
unusual changes in mood or behavior, or have thoughts of hurting
yourself.
Do not take INGREZZA if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA.
INGREZZA may cause serious side effects, including:
- Sudden swelling from an allergic reaction (angioedema).
Sudden swelling has happened after the first dose or after many
doses of INGREZZA. Signs and symptoms of angioedema include:
swelling of your face, lips, throat, and other areas of your skin,
difficulty swallowing or breathing, and raised, red areas on your
skin (hives). Swelling in the throat can be life-threatening and
can lead to death. Go to the nearest emergency room right away if
you develop these signs and symptoms. Your healthcare provider
should stop your treatment with INGREZZA.
- Heart rhythm problems (QT prolongation). INGREZZA may
cause a heart problem known as QT prolongation. Symptoms of QT
prolongation may include: fast, slow, or irregular heartbeat,
dizziness or fainting, or shortness of breath.
Tell your healthcare provider right away if you have a change in
your heartbeat (a fast or irregular heartbeat), or if you
faint.
- Neuroleptic Malignant Syndrome (NMS): NMS is a serious
condition that can lead to death. Call a healthcare provider right
away or go to the nearest emergency room if you develop these
symptoms and they do not have another obvious cause: high fever,
stiff muscles, problems thinking, very fast or uneven heartbeat, or
increased sweating.
- Abnormal movements (Parkinson-like). Symptoms include:
shaking, body stiffness, trouble moving or walking, or keeping your
balance.
Before taking INGREZZA, tell your healthcare provider about
all of your medical conditions including if you: have liver or
heart problems, are pregnant or plan to become pregnant, or are
breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
Sleepiness (sedation) is a common side effect with
INGREZZA. While taking INGREZZA, do not drive a car or operate
dangerous machinery until you know how INGREZZA affects you.
Drinking alcohol and taking other drugs that may also cause
sleepiness while you are taking INGREZZA may increase any
sleepiness caused by INGREZZA.
The most common side effect of INGREZZA in people with
tardive dyskinesia is sleepiness
(somnolence).
The most common side effects of INGREZZA in people with
Huntington's disease are
sleepiness (somnolence), allergic itching, rash, and trouble
getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit MedWatch at www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see INGREZZA full Prescribing
Information, including Boxed Warning.
About Huntington Study Group / HSG Clinical
Research, Inc.
The Huntington Study Group (HSG), a
not-for-profit organization founded in 1993 in Rochester, NY, and its wholly owned
subsidiary, HSG Clinical Research, Inc., designs and conducts
clinical trials through the world's first and largest collaborative
network with thousands of members at more than 130 HSG credentialed
research sites worldwide. HSG collaborated with the respective
study sponsors to complete three pivotal clinical trials that led
to the FDA-approved medications for Huntington's disease chorea. HSG is dedicated
to improving the lives of people impacted by Huntington's disease through research,
education, and collaboration. For more information,
visit HuntingtonStudyGroup.org.
The KINECT-HD study was conducted in cooperation with the HSG
and the Clinical Trials Coordination Center (CTCC) at the
University of Rochester Medical
Center's Center for Health + Technology (CHeT). For more
information, visit
urmc.Rochester.edu/Health-Technology/Our-Expertise/Clinical-Trials-Coordination.aspx.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a leading neuroscience-focused, biopharmaceutical
company with a simple purpose: to relieve suffering for people with
great needs, but few options. We are dedicated to discovering and
developing life-changing treatments for patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric
disorders. The company's diverse portfolio includes FDA-approved
treatments for tardive dyskinesia, chorea associated with
Huntington's disease, Parkinson's
disease, endometriosis* and uterine fibroids*, as well as a robust
pipeline including multiple compounds in mid- to late-phase
clinical development across our core therapeutic areas. For three
decades, we have applied our unique insight into neuroscience and
the interconnections between brain and body systems to treat
complex conditions. We relentlessly pursue medicines to ease the
burden of debilitating diseases and disorders, because you deserve
brave science. For more information,
visit Neurocrine.com, and follow the company on LinkedIn,
Twitter and Facebook. (*in collaboration with AbbVie)
NEUROCRINE, the Neurocrine logos, INGREZZA, the INGREZZA logos
and KINECT are registered trademarks of Neurocrine Biosciences,
Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and
uncertainties. These statements include, but are not limited to,
statements regarding the potential benefits to be derived from
INGREZZA for the treatment of chorea associated with Huntington's disease (HD), and the value
INGREZZA for the treatment of chorea associated with HD brings to
patients. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements include: risks and uncertainties associated with
Neurocrine Biosciences' business and finances in general, as well
as risks and uncertainties associated with the commercialization of
INGREZZA for the treatment of chorea associated with HD; whether
INGREZZA for the treatment of chorea associated with HD receives
adequate reimbursement from third-party payors; the degree and pace
of market uptake of INGREZZA for the treatment of chorea associated
with HD; risks and uncertainties relating to competitive products
and technological changes that may limit demand for INGREZZA for
the treatment of chorea associated with HD; risks associated with
the Company's dependence on third parties for development and
manufacturing activities related to INGREZZA for the treatment of
chorea associated with HD, and the ability of the Company to manage
these third parties; risks that additional regulatory submissions
for INGREZZA for the treatment of chorea associated with HD or
other product candidates may not occur or be submitted in a timely
manner; risks that the FDA or other regulatory authorities may make
adverse decisions regarding INGREZZA for the treatment of chorea
associated with HD; risks that post-approval INGREZZA for the
treatment of chorea associated with HD commitments or requirements
may be delayed; risks that INGREZZA for the treatment of chorea
associated with HD may be precluded from commercialization by the
proprietary rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA for the treatment of
chorea associated with HD; and other risks described in the
Company's periodic reports filed with the Securities and Exchange
Commission, including without limitation the Company's quarterly
report on Form 10-Q for the quarter ended June 30, 2023. Neurocrine Biosciences disclaims
any obligation to update the statements contained in this press
release after the date hereof.
©2023 Neurocrine Biosciences, Inc. All Rights Reserved.
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