- Data Support Positive Impact of INGREZZA in People With
Huntington's Disease Chorea
- Findings Presented at the 2024 Annual Meeting of the Huntington
Study Group
SAN
DIEGO, Nov. 7, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today presented subgroup
analyses and data from the KINECT®-HD study showing the
impact of INGREZZA® (valbenazine) capsules on emotional
health and psychiatric stability in patients with chorea associated
with Huntington's disease. The subgroup analysis showed consistent
efficacy in reducing chorea compared to placebo across all
identified subgroups, categorized by demographics and baseline
assessment scores. A separate data analysis showed improvements in
some aspects of emotional health with no worsening of psychiatric
symptoms. This research will be shared at the 2024 Annual Meeting
of the Huntington Study Group in Cincinnati.
"In addition to physical symptoms, Huntington's disease
significantly affects emotional and psychological health, often
leading to increased anxiety and irritability or anger," said Eiry
W. Roberts, M.D., Chief Medical Officer, Neurocrine
Biosciences. "These data not only support the consistent efficacy
of INGREZZA in reducing chorea across various subgroups but also
its potential positive impact on emotional health in patients
because of the reduced movements."
Efficacy of Valbenazine for Chorea Associated with
Huntington's Disease: Subgroup Analyses of KINECT®-HD
Results
This analysis was conducted to assess the effects of INGREZZA
(n=64) versus placebo (n=61) in subgroups of participants from the
Phase 3 KINECT-HD study using the Unified Huntington's Disease
Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score.
Participants in the study were randomized 1:1 to receive placebo or
INGREZZA, with a starting dose of 40 mg that was increased up to 80
mg over an 8-week period as tolerated, for a total treatment period
of 12 weeks. In the full analysis set, least-squares mean (LSM)
changes for TMC score indicated significantly greater chorea
improvements for INGREZZA versus placebo, with an LSM difference at
maintenance of -3.2 (95% confidence interval (CI): -4.4 to -2.0;
P < 0.0001). To further assess INGREZZA efficacy, TMC
changes were analyzed in subgroups categorized by demographics
(sex, age and body mass index) and baseline assessment scores
(Clinical Global Impression of Severity, Patient Global Impression
of Severity, Anosognosia Scale, UHDRS Total Functional Capacity,
UHDRS Total Motor Score and UHDRS TMC).
TMC changes favored INGREZZA over placebo in all 19 subgroups,
with the LSM difference (LSMD; 95% CI) ranging from -4.5 (-6.6 to
-2.4) to -1.6 (-4.1 to 0.8). Results were favorable for INGREZZA in
17 of the 19 subgroups. The 95% CIs for all subgroup LSMDs
encompassed the primary endpoint LSMD of -3.2.
Effects of Valbenazine on Emotional Health and Psychiatric
Stability in Adults with Huntington's Disease
This separate post hoc analysis of the Phase 3 KINECT-HD study
was conducted to evaluate emotional health and psychiatric
stability in participants taking INGREZZA (n=64) or placebo (n=61)
utilizing the Huntington's Disease Health Index (HD-HI) Emotional
Health subscale. Mean score changes from baseline (CFB) to Week 10
and Week 12 were analyzed in "affected" participants (those with a
baseline item score of at least 2). Safety assessments included
adverse events of special interest (AESIs), the Hospital Anxiety
and Depression Scale (HADS) and the Columbia-Suicide Severity
Rating Scale (C-SSRS).
Results showed that some aspects of emotional health appeared to
improve with INGREZZA in affected participants. The largest score
changes with INGREZZA compared to placebo at Week 12 were:
- Anger: -1.7 (INGREZZA; n=17) versus -0.2 (placebo; n=22)
- Feeling of being overwhelmed: -1.7 (n=20) versus -0.4
(n=27)
- Fluctuating mood: -1.5 (n=15) versus -0.4 (n=23)
- Reduced enjoyment with activities: -1.5 (n=25) versus -0.4
(n=26)
- Emotional outbursts: -1.5 (n=15) versus -0.6 (n=23)
- Frustration: -1.3 (n=25) versus -0.4 (n=28)
- Anxiety: -1.4 (n=25) versus -0.5 (n=30)
In the safety population (N=127), 5 participants (3 INGREZZA, 2
placebo) reported AESIs related to depression or suicidal ideation.
HADS and C-SSRS shifts from baseline indicated no worsening in
anxiety symptoms, depression symptoms or suicidal ideation with
INGREZZA.
Additional Neurocrine Biosciences posters presented at the
2024 Annual Meeting of the Huntington Study Group include:
- Huntington's Disease Health Index (HD-HI) Correlations with
Clinical Measures: An Analysis of KINECT®-HD Baseline
Data
- Somnolence-Related Events Over Time with Valbenazine Treatment
for Chorea Associated with Huntington's Disease
- Efficacy of Once-Daily Valbenazine in Adults with Chorea
Associated with Huntington's Disease: Effect Size Over Time
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 was 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 substantial 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. The most
common adverse reactions in patients with HD included somnolence
and sedation, urticaria, rash and insomnia.
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 and
INGREZZA® SPRINKLE (valbenazine)
Capsules
INGREZZA is a 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). Only INGREZZA offers a therapeutic dose from day one with no
required titration.
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 is unique in that it selectively and specifically 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.
INGREZZA is always one capsule, once daily and can be taken
together with most stable mental health regimens such as
antipsychotics or antidepressants. Only INGREZZA offers the benefit
of a sprinkle formulation, INGREZZA® SPRINKLE, for those
who experience dysphagia, have difficulty swallowing or prefer not
to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved
for use are 40 mg, 60 mg and 80 mg capsules.
Important Information
Approved
Uses
INGREZZA® (valbenazine) capsules or
INGREZZA® SPRINKLE (valbenazine) capsules are
prescription medicines 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 or INGREZZA SPRINKLE do not cure the cause of involuntary
movements, and do not treat other symptoms of Huntington's disease,
such as problems with thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE 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 or INGREZZA
SPRINKLE 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 or INGREZZA
SPRINKLE 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 or INGREZZA SPRINKLE if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects,
including:
- Allergic reactions. Allergic reactions, including an
allergic reaction that causes sudden swelling called angioedema can
happen after taking the first dose or after many doses of INGREZZA
or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and
angioedema include: trouble breathing or shortness of breath,
swelling of your face, lips, eyelids, tongue, or throat, or other
areas of your skin, trouble with swallowing, or rash, including
raised, itchy red areas on your skin (hives). Swelling in the
throat can be life-threatening and can lead to death. Stop taking
INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room
right away if you develop these signs and symptoms of allergic
reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction
times (somnolence and sedation). Do not drive a car or operate
dangerous machinery until you know how INGREZZA or INGREZZA
SPRINKLE affects you. Drinking alcohol and taking other medicines
may also cause sleepiness during treatment with INGREZZA or
INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA or
INGREZZA SPRINKLE may cause a heart rhythm problem known as QT
prolongation. You have a higher chance of getting QT prolongation
if you also take certain other medicines during treatment with
INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right
away if you develop any signs or symptoms of QT prolongation,
including: fast, slow, or irregular heartbeat (heart palpitations),
shortness of breath, dizziness or lightheadedness, or fainting or
feeling like you are going to 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, irregular pulse or blood
pressure, increased sweating, or very fast or uneven heartbeat.
- Parkinson-like symptoms. Symptoms include: body
stiffness, drooling, trouble moving or walking, trouble keeping
your balance, shaking (tremors), or falls.
Before taking INGREZZA or INGREZZA SPRINKLE, 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. Make sure you tell all
of your healthcare providers that you are taking INGREZZA or
INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with
certain other medicines may cause serious side effects. Especially
tell your healthcare provider if you: take digoxin or take or have
taken a monoamine oxidase inhibitor (MAOI) medicine. You should not
take INGREZZA or INGREZZA SPRINKLE if you are taking, or have
stopped taking, a MAOI within the last 14 days.
The most common side effect of INGREZZA or INGREZZA SPRINKLE
in people with tardive dyskinesia are sleepiness
and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with chorea associated with Huntington's disease
include sleepiness and tiredness, raised itchy red areas on
your skin (hives), rash, and trouble getting to sleep or staying
asleep.
These are not all of the possible side effects of INGREZZA or
INGREZZA SPRINKLE. 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.
Dosage Forms and Strengths: INGREZZA and INGREZZA
SPRINKLE are available in 40 mg, 60 mg, and 80 mg
capsules.
Please see full Prescribing Information,
including Boxed Warning, and Medication Guide.
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, 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, X (formerly Twitter) and Facebook.
(*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE
BRAVE SCIENCE, KINECT and INGREZZA 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 may
bring to patients with chorea associated with HD. Factors that
could cause actual results to differ materially from those stated
or implied in the forward-looking statements include, but are not
limited to, the following: 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 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 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 or regulatory 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 September 30, 2024. Neurocrine
Biosciences disclaims any obligation to update the statements
contained in this press release after the date hereof other than
required by law.
© 2024 Neurocrine Biosciences, Inc. All Rights Reserved
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SOURCE Neurocrine Biosciences, Inc.