SAN
DIEGO, Nov. 2, 2023 /PRNewswire/
-- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced
interim results from the ongoing open-label KINECT®-HD2
study about INGREZZA® (valbenazine) capsules when used
for the long-term treatment of adults with chorea associated with
Huntington's disease (HD). Interim
data suggest one-capsule, once-daily INGREZZA improved chorea at
the first evaluation at Week 2 with sustained efficacy through Week
50. These data will be presented at the 30th Annual Meeting of the
Huntington Study Group on November 2–4 in Phoenix.
"These interim data provide insight on the clinically meaningful
and sustained improvements participants are experiencing with
INGREZZA for the treatment of chorea," said Eiry W. Roberts, M.D.,
Chief Medical Officer at Neurocrine Biosciences®. "We
look forward to analyzing additional data as they become
available."
KINECT-HD2 includes adults with genetically confirmed
motor-manifest HD (n=127), most of whom (n=98) completed KINECT-HD,
a Phase 3, randomized, double-blind, placebo-controlled study. Both
studies were conducted in collaboration with the Huntington Study
Group (HSG) and contributed to the recent U.S. Food and Drug
Administration approval of INGREZZA for chorea associated with HD.
Concomitant antipsychotic use is also being explored in the
open-label study.
The current interim results from KINECT-HD2 (Sustained
Improvements With Once-Daily Valbenazine in Chorea Associated With
Huntington's Disease: Interim Results From a Long-Term Open-Label
Study, Poster # 64) suggest that INGREZZA improved chorea at the
first evaluation (Week 2) when participants were taking the lowest
dose of 40 mg, with efficacy sustained through Week 50 at ≤ 80 mg
(Figure 1).
More than half of participants (60.9 percent) and investigators
(58.9 percent) rated symptoms as "much improved" or "very much
improved" at Week 6, and about three-quarters of participants (74.2
percent) and investigators (76.9 percent) rated symptoms as "much
improved" or "very much improved" by Week 50. The most common
treatment-emergent adverse events at the time of the analysis were
consistent with those observed in KINECT-HD, including falls (30.4
percent), fatigue (24.0 percent) and somnolence (24.0 percent).
Neurocrine Biosciences will also present new data from KINECT-HD
(A Wearable Movement Sensor Substudy of KINECT-HD, a Phase 3 Trial
of Valbenazine for the Treatment of Chorea Associated With
Huntington's Disease, Poster #65), which was the first Phase 3
clinical trial to include a wearable movement sensor substudy.
Significant improvements in truncal chorea and gait asymmetry
measures were seen from baseline to maintenance following the Week
10 visit in the INGREZZA-treated group (P < 0.05)
compared to placebo. These findings support how digital
measurements can be used to detect meaningful symptom changes in
individuals with HD to improve clinical research and care.
Additional HD chorea presentations at the 30th Annual Meeting of
the HSG include:
- The Huntington's Disease
Health Index (HD-HI): Measuring Changes in Disease Burden in
Response to Valbenazine During the KINECT®-HD Trial
(Poster #66)
- A Minimal Clinically Important Difference
for UHDRS® Total Maximal Chorea Score as a Measure
of Chorea Severity in Huntington's
Disease (Poster #63)
- Indirect Treatment Comparison of Valbenazine With
Deutetrabenazine for Improvement in Total Maximal Chorea Score in
Huntington's Disease (Poster
#62)
The full abstracts can be accessed on the Journal of
Huntington's
Disease website.
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 KINECT®-HD2
KINECT®-HD2 is an ongoing open-label study to evaluate
the long-term safety and tolerability, as well as the maintenance
of effects, of INGREZZA in patients with chorea associated
with Huntington's disease (HD). The 156-week study has
enrolled more than 150 adults 18 to 75 years of age who have
been diagnosed with motor-manifest HD and who have sufficient
chorea symptoms to meet study protocol criteria. Concomitant
antipsychotic use is allowed in the study. For more information on
the KINECT-HD2 study, please visit HuntingtonStudyGroup.org or
ClinicalTrials.gov.
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 the three pivotal clinical trials that
led to the only FDA-approved medications for Huntington's disease associated chorea. The
organization is dedicated to improving the lives of people impacted
by Huntington's disease through
research, education, and collaboration. For more information,
visit www.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 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 Neurocrine Biosciences
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, X (formerly Twitter) and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE, NEUROCRINE BIOSCIENCES, the Neurocrine logo,
INGREZZA, the INGREZZA logo 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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SOURCE Neurocrine Biosciences, Inc.