- Treatment with ruxolitinib cream (Opzelura™)
resulted in facial repigmentation at Week 24, characterized by a
significant proportion of patients achieving ≥75% improvement from
baseline in the facial Vitiligo Area Scoring Index
- A significantly greater proportion of
patients treated with ruxolitinib cream also achieved ≥50%
improvement from baseline in total body Vitiligo Area Scoring Index
(T-VASI50)
- Results will be presented in a late-breaking
oral presentation at the European Academy of Dermatology and
Venereology (EADV) 30th Congress
Incyte (Nasdaq:INCY) today announced the full 24-week results
from its pivotal Phase 3 TRuE-V clinical trial program
investigating ruxolitinib cream (Opzelura™), a topical JAK
inhibitor, in adolescent and adult patients (age ≥12 years) with
nonsegmental vitiligo. These data will be presented today as a
late-breaking oral presentation (Abstract #D3T01.2A) at the
European Academy of Dermatology and Venereology (EADV) 30th
Congress, held virtually from September 29-October 2, 2021.
Building on the previously announced positive topline results
from the TRuE-V program, findings from the Week 24 analysis showed
treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in
greater improvement to vehicle for the primary and all key
secondary endpoints in both the TRuE-V1 and TRuE-V2 studies.
Results, which were consistent across both studies, showed:
- At Week 24, 29.9% of patients applying ruxolitinib cream
achieved ≥75% improvement from baseline in the facial Vitiligo Area
Scoring Index (F-VASI75), the primary endpoint.
- More than 51% of patients applying ruxolitinib cream achieved
≥50% improvement from baseline in F-VASI (F-VASI50), and more than
15% of patients applying ruxolitinib cream achieved ≥90%
improvement from baseline in F-VASI (F-VASI90), key secondary
endpoints.
- Additional key secondary endpoints were met, including a
significantly greater proportion of patients achieving ≥50%
improvement from baseline in total body Vitiligo Area Scoring Index
(T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with
application of ruxolitinib cream compared to vehicle, and a
significant improvement on percentage change from baseline in
facial body surface area (F-BSA) with application of ruxolitinib
cream compared to vehicle.
“We are pleased to share the full 24-week results from our
pivotal Phase 3 TRuE-V program for the first time with the global
dermatology community at EADV, which resulted in significant
improvements in facial and total body repigmentation in vitiligo
patients treated with ruxolitinib cream,” said Jim Lee, M.D.,
Ph.D., Group Vice President, Inflammation & Autoimmunity,
Incyte. “These positive results reinforce the potential for
ruxolitinib cream as a meaningful treatment option for people
suffering from vitiligo, and we look forward to working with
regulators to bring the first approved medical treatment that
directly addresses repigmentation to patients in the U.S. and
Europe.”
The overall safety profile of ruxolitinib cream in vitiligo was
consistent with previous study data. In the TRuE-V studies,
patients using ruxolitinib cream did not report clinically
significant application site reactions. Treatment-emergent adverse
events were consistent with previous studies, with no serious
treatment-related adverse events reported.
“The skin depigmentation associated with vitiligo can have a
profound impact on a person’s life and patients are in need of
additional treatment options,” said David Rosmarin, M.D., Vice
Chair of Research and Education, Dermatology Department at Tufts
Medical Center. “I am extremely encouraged about the potential of
ruxolitinib cream, as evidenced by the clinically meaningful
improvements in repigmentation shown in the pivotal trials, and the
potential benefits it may bring for my patients.”
As previously disclosed, based on these findings Incyte expects
to submit marketing applications for ruxolitinib cream for the
treatment of adolescent and adult patients with vitiligo (age ≥12
years) to the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) before the end of 2021. In
September 2021, Opzelura™ (ruxolitinib) cream was approved by the
FDA for the short-term and non-continuous treatment of mild to
moderate atopic dermatitis (AD) in non-immunocompromised patients
12 years of age and older whose disease is not adequately
controlled with topical prescription therapies, or when those
therapies are not advisable.
About Vitiligo Vitiligo is a chronic autoimmune disease
characterized by depigmentation of skin that results from the loss
of pigment-producing cells known as melanocytes. Over-activity of
the JAK signaling pathway has been shown to drive inflammation
involved in the pathogenesis and progression of vitiligo. It
affects approximately 0.5% to 2.0% of the population globally1 and
there are no U.S. Food and Drug Administration (FDA) or European
Medicines Agency (EMA)-approved drug therapies for the treatment of
vitiligo. It can occur at any age, although many patients with
vitiligo will experience initial symptoms before the age of
202.
About TRuE-V The TRuE-V clinical trial program includes
two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2
(NCT04057573), evaluating the safety and efficacy of ruxolitinib
cream in patients with vitiligo.
The studies each enrolled approximately 300 patients (age ≥12
years) who have been diagnosed with non-segmental vitiligo and have
depigmented areas including at least 0.5% of the body surface area
(BSA) on the face, ≥0.5 facial Vitiligo Area Scoring Index [F-VASI]
score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo
Area Scoring Index [T-VASI] score and total BSA involvement (facial
and nonfacial) of up to 10%. Participants were randomized into two
arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control
for the 24-week double-blind period. Patients who successfully
completed baseline and Week 24 assessments, including those that
received vehicle control during the double-blind phase, were
offered treatment extension with 1.5% ruxolitinib cream BID for an
additional 28 weeks.
The primary endpoint of both studies in the TRuE-V program is
the proportion of patients achieving F-VASI75, defined as at least
a 75% improvement from baseline in the F-VASI score at Week 24. Key
secondary endpoints include: the percentage change from baseline in
facial BSA (F-BSA) at Week 24, the proportion of patients achieving
F-VASI50 (at least 50% improvement from baseline in the F-VASI),
F-VASI90 (at least 90% improvement from baseline in the F-VASI) and
T-VASI50 (at least 50% improvement from baseline in the T-VASI) at
Week 24, the proportion of patients achieving F-VASI75, F-VASI90,
T-VASI50 and T-VASI75 (at least 75% improvement from baseline in
the T-VASI) at Week 52 and the proportion of patients achieving a
Vitiligo Noticeability Scale (VNS) score of 4 (a lot less
noticeable) or 5 (no longer noticeable) at Week 24. The studies
also track the frequency, duration and severity of adverse events
associated with the use of ruxolitinib cream.
For more information on the TRuE-V studies, please visit
https://clinicaltrials.gov/ct2/show/NCT04052425 and
https://clinicaltrials.gov/ct2/show/NCT04057573.
About Opzelura™ (ruxolitinib) Cream Opzelura, a novel
cream formulation of Incyte’s selective JAK1/JAK2 inhibitor
ruxolitinib, is the first and only topical JAK inhibitor approved
for use in the United States for the topical short-term and
non-continuous chronic treatment of mild to moderate atopic
dermatitis (AD) in non-immunocompromised patients 12 years of age
and older whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.
Use of Opzelura in combination with therapeutic biologics, other
JAK inhibitors, or potent immunosuppressants, such as azathioprine
or cyclosporine, is not recommended.
Additionally, ruxolitinib cream is in Phase 3 development for
the treatment of adolescents and adults with vitiligo in the TRuE-V
clinical program. Results from this Phase 3 program were recently
announced.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA cream is for use on the skin only. Do not use OPZELURA
cream, in your eyes, mouth or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA cream contains ruxolitinib.
Ruxolitinib belongs to a class of medicines called Janus kinase
(JAK) inhibitors. JAK inhibitors are medicines that affect your
immune system. JAK inhibitors can lower the ability of your immune
system to fight infections. Some people have had serious infections
while taking JAK inhibitors by mouth, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses that can
spread throughout the body. Some people have been hospitalized or
died from these infections. Some people have had serious infections
of their lungs while taking OPZELURA. Your healthcare provider
should watch you closely for signs and symptoms of TB during
treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious
infection, including localized infections. You should not start
using OPZELURA if you have any kind of infection unless your
healthcare provider tells you it is okay. You may be at a higher
risk of developing shingles (herpes zoster) while using
OPZELURA.
Increased risk of death from all causes, including sudden
cardiac death, has happened in people taking JAK inhibitors by
mouth.
Cancer and immune system problems: OPZELURA may increase
your risk of certain cancers by changing the way your immune system
works. Some people have had lymphoma and other cancers while taking
JAK inhibitors by mouth, especially if they are a current or past
smoker. Some people have had skin cancers while taking OPZELURA.
Your healthcare provider will regularly check your skin during your
treatment with OPZELURA.
There is an increased risk of major cardiovascular events
such as heart attack, stroke or cardiac death in people with
cardiovascular risk factors and who are current or past smokers
while using JAK inhibitors to treat inflammatory
conditions.
Blood clots: Blood clots in the veins of your legs (deep
vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen
in some people taking OPZELURA. This may be life-threatening.
Low blood cell counts: OPZELURA may cause low platelet
counts (thrombocytopenia), low red blood cell counts (anemia), and
low white blood cell counts (neutropenia). If needed, your
healthcare provider will do a blood test to check your blood cell
counts during your treatment with OPZELURA and may stop your
treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened
in people when ruxolitinib is taken by mouth. Tell your healthcare
provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if
you:
- have an infection, are being treated for one, or have an
infection that keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune
system
- have or had TB, or have been in close contact with someone with
TB
- have had shingles (herpes zoster) or hepatitis B or C
- live, have lived in, or have traveled to certain parts of the
country (such as the Ohio and Mississippi River valleys and the
Southwest) where there is an increased chance for getting certain
kinds of fungal infections. These infections may happen or become
more severe if you use OPZELURA. Ask your healthcare provider if
you do not know if you have lived in an area where these infections
are common.
- think you have an infection or have symptoms of an infection
such as:
- fever, sweating, or chills
- muscle aches
- cough or shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinating more often than
usual
- feeling very tired
- have ever had any type of cancer, or are a current or past
smoker
- have had blood clots in the veins of your legs or lungs in the
past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if
OPZELURA will harm your unborn baby. There is a pregnancy exposure
registry for individuals who use OPZELURA during pregnancy. The
purpose of this registry is to collect information about the health
of you and your baby. If you become exposed to OPZELURA during
pregnancy, you and your healthcare provider should report exposure
to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if
OPZELURA passes into your breast milk. Do not breastfeed during
treatment with OPZELURA and for about 4 weeks after the last
dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any
symptoms of an infection. OPZELURA can make you more likely to get
infections or make worse any infections that you have.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than
a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs
and symptoms of blood clots during treatment with OPZELURA,
including: swelling, pain or tenderness in one or both legs,
sudden, unexplained chest or upper back pain, or shortness of
breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have
worsening of any symptoms of low blood cell counts, such as:
unusual bleeding, bruising, tiredness, shortness of breath or
fever.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
The most common side effects of OPZELURA include: pain or
swelling in your nose or throat (nasopharyngitis), diarrhea,
bronchitis, ear infection, increase in a type of white blood cell
(eosinophil) count, hives, inflamed hair pores (folliculitis),
swelling of the tonsils (tonsillitis), and runny nose
(rhinorrhea).
These are not all of the possible side effects of OPZELURA. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. You may also report side
effects to Incyte Corporation at 1-855-463-3463.
About Incyte Dermatology Incyte’s science-first approach
and expertise in immunology has formed the foundation of the
company. In Dermatology, the Company’s research and development
efforts are focused on leveraging our knowledge of the JAK-STAT
pathway to identify and develop topical and oral therapies with the
potential to modulate immune pathways driving uncontrolled
inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition
for a number of immune-mediated dermatologic conditions with a high
unmet medical need, including vitiligo and hidradenitis
suppurativa. To learn more, visit the Dermatology section of
Incyte.com.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
Forward-Looking Statements Except for the historical
information set forth herein, the matters set forth in this press
release, including statements regarding Incyte’s TRuE-V clinical
program, whether and when ruxolitinib cream might be approved to
treat patients with vitiligo , the potential for success of such
treatment, Incyte’s expectations with respect to submitting
marketing applications for ruxolitinib cream for the treatment of
adolescent and adult patients with vitiligo to regulators and
Incyte’s Dermatology program generally, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; the effects of the COVID-19 pandemic and measures to
address the pandemic on the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by the FDA, EMA and other
regulatory authorities; the efficacy or safety of the Company’s
products; the acceptance of the Company’s products in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; and other risks detailed from time
to time in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report and its quarterly
report on Form 10-Q for the quarter ended June 30, 2021. The
Company disclaims any intent or obligation to update these
forward-looking statements.
________________ 1 Kruger C. A review of the worldwide
prevalence of vitiligo in children/adolescents and adults. Int J
Dermatol. 2012;51(10):1206-1212. 2 Rodrigues M. New Discoveries in
the pathogenesis and classification of vitiligo. J Am Acad
Dermatol. 2017; 77:1-13.
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version on businesswire.com: https://www.businesswire.com/news/home/20211002005006/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Erica Cech +1 302 274 4324 ecech@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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