- KINECT®-HD2 Is the First Prospective Clinical
Trial to Include Patients Taking Antipsychotic Medication in a
Study Evaluating a Vesicular Monoamine Transporter 2 (VMAT2)
Inhibitor for the Treatment of Huntington's Disease
Chorea
- Findings Presented at the 2024 MDS International Congress
of Parkinson's Disease and Movement Disorders®
SAN
DIEGO, Sept. 30, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced
interim results from the ongoing open-label KINECT®-HD2
study of INGREZZA® (valbenazine) capsules for the
long-term treatment of adults with chorea associated with
Huntington's disease. Robust and sustained improvements in
chorea associated with Huntington's disease were observed through
Week 104 in patients, irrespective of concomitant antipsychotic
therapy use. These results (Poster #1465) will be presented on
September 30 during the 2024 MDS
International Congress of Parkinson's Disease and Movement
Disorders® in Philadelphia.
"The data from this study reinforce the long-term clinical
safety of INGREZZA observed to date, showing sustained improvement
in chorea regardless of antipsychotic use during the study," said
Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine
Biosciences. "This is an important finding given that approximately
a third of patients living with Huntington's disease chorea are
prescribed antipsychotic medications for neuropsychiatric symptoms
without receiving treatment for the chorea that may significantly
disrupt daily life."
The effect of INGREZZA on chorea over time was assessed using
mean changes from baseline in the Unified Huntington's Disease
Rating Scale Total Maximal Chorea (TMC) score and response status
("much improved" or "very much improved") for Clinical Global
Impression of Change and Patient Global Impression of Change.
Data from this interim analysis of KINECT-HD2 suggest robust and
sustained improvements in Huntington's disease (HD) chorea with
INGREZZA treatment:
- INGREZZA improved HD chorea as early as Week 2 (TMC change from
baseline: -3.4) at the starting dose of 40 mg and at Week 4 (-4.6)
with doses up to 60 mg. Efficacy was sustained from Week 8 (-5.7)
to Week 104 (-5.2) at the maintenance dose of up to 80 mg.
- These improvements were consistent regardless of presence or
absence of concomitant antipsychotic treatment.
- At Week 6 and at each visit thereafter, more than half of
participants and investigators rated symptoms as "much improved" or
"very much improved." At Week 104, this response status was
achieved in 75.9% of participants based on self-report and 73.6% of
participants based on clinician assessment.
- The most common treatment-emergent adverse events at the time
of the analysis were consistent with those observed in KINECT-HD,
including falls, somnolence and fatigue.
Additional presentations by Neurocrine Biosciences
include:
- Somnolence-Related Events Over Time with Valbenazine Treatment
for Chorea Associated with Huntington's Disease (Poster #1445)
- Treatment Effect Sizes of Once-Daily Valbenazine for Tardive
Dyskinesia and for Chorea Associated with Huntington's Disease: A
Post-Hoc Analysis of Phase 3 Clinical Trial Data (Poster
#1466)
About Chorea Associated with Huntington's
Disease
Huntington's disease 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 maintenance period up to week 156 of treatment enrolled
154 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 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
(TD) and the treatment of chorea associated with Huntington's
disease (HD) that is always one capsule, once daily with no complex
dose adjustments to get to an effective dose. Only INGREZZA offers
a therapeutic dose from day one.
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 can be taken as one capsule, once daily 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 effects 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
https://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 June 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-interim-data-demonstrating-robust-and-sustained-improvements-in-chorea-associated-with-huntingtons-disease-through-week-104-irrespective-of-antipsychotic-use-302261878.html
SOURCE Neurocrine Biosciences, Inc.
