- Three late-breaking presentations in vitiligo highlight new
long-term data from the Phase 3 TRuE-V trials for Opzelura®
(ruxolitinib) cream and results from a Phase 2b study with
povorcitinib (INCB54707), an oral JAK1 inhibitor
- Incyte to host an in-person analyst and investor event on
Saturday, March 18, 2023, from 5:30-7:00 p.m. CT to discuss key
vitiligo data presentations
Incyte (Nasdaq:INCY) today announced that multiple abstracts
featuring data from its dermatology portfolio will be presented at
the upcoming 2023 American Academy of Dermatology (AAD) Annual
Meeting, held March 17-21, 2023, in New Orleans.
New data from the Phase 3 TRuE-V clinical trial program
evaluating the durability and long-term response (up to 104 weeks)
of Opzelura® (ruxolitinib) cream in patients (age ≥12 years) with
vitiligo will be presented in two late-breaking oral presentations,
building on the previously announced positive 24- and 52-week
results from the TRuE-V1 and TRuE-V2 studies. Additionally, safety
and efficacy data from a Phase 2b study of povorcitinib, an
investigational oral small-molecule JAK1 inhibitor, in patients
with vitiligo will be presented as an oral presentation during a
late-breaking abstract session.
“The research being featured at this year’s AAD Annual Meeting
highlights the potential of Incyte therapies to meet the needs of
patients living with vitiligo and other serious skin conditions,”
said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation &
Autoimmunity, Incyte. “Collectively, these data are representative
of our science-first approach and the continued progress of our
portfolio as we seek to discover and develop innovative dermatology
treatments for patients.”
Key abstracts include:
Late-Breaking Oral
Presentations
Vitiligo
Relapse and Maintenance of Clinical Response in the
Randomized Withdrawal Arm of the TRuE-V Long-Term Extension Phase 3
Study of Ruxolitinib Cream in Vitiligo (Session: S025 –
Late-Breaking Research: Session 1. Saturday, March 18, 9:20 a.m.
CT)
Facial and Total Vitiligo Area Scoring Index Response Shift
During 104 Weeks of Ruxolitinib Cream Treatment for Vitiligo:
Results from the Open-Label Arm of the TRuE-V Long-Term Extension
Phase 3 Study (Session: S025 – Late-Breaking Research: Session
1. Saturday, March 18, 9:30 a.m. CT)
Efficacy and Safety of Povorcitinib in Vitiligo: Results from
a Phase 2, Placebo-Controlled, Dose Ranging Study (Session:
S042 – Late-Breaking Research: Session 2. Saturday, March 18, 2:30
p.m. CT)
Posters with Oral
Presentation
Atopic Dermatitis
Ruxolitinib Cream Monotherapy Use Demonstrates Maintenance of
Disease and Symptom Control with Use as Needed in Adults and
Adolescents with Atopic Dermatitis: Pooled Analysis from the
Long-Term Safety Periods of Two Phase 3 Studies (Abstract
#44103. Session: Atopic Dermatitis. Friday, March 17, 2023, 3:20
p.m. – 3:25 p.m. CT)
Hidradenitis Suppurativa
Changes in Draining Tunnel (dT) Counts in the Randomized,
Placebo-Controlled, Phase 2 Study of Povorcitinib (INCB054707) in
Patients with Hidradenitis Suppurativa (HS) (Abstract #44062.
Session: Immunodermatology & Blistering Disorders. Saturday,
March 18, 2023, 10:40 a.m. – 10:45 a.m. CT)
Vitiligo
Vitiligo Noticeability Scale Score Maintenance or Shift
During 52 Weeks of Ruxolitinib Cream Treatment for Vitiligo: Pooled
Analysis of the TRuE-V Phase 3 Studies (Abstract #43959.
Session: Pigmentary Disorders & Vitiligo. Saturday, March 18,
2023, 5:50 p.m. – 5:55 p.m. CT)
Facial Vitiligo Area Scoring Index Response Maintenance or
Shift During 52 Weeks of Ruxolitinib Cream Treatment for Vitiligo:
Pooled Analysis of the TRuE-V Phase 3 Studies (Abstract #43912.
Session: Pigmentary Disorders & Vitiligo. Saturday, March 18,
2023, 5:35 p.m. – 5:40 p.m. CT)
e-Poster Exhibits
For e-Poster exhibits, abstract content will be available in the
online viewing portal and on-site at the viewing stations. They
will also be published online via the Journal of the American
Academy of Dermatology (JAAD) supplement in Fall 2023.
Graft-Versus-Host Disease (GVHD)
Oral Ruxolitinib Treatment for Patients with Dermatologic
Manifestations of Acute or Chronic Graft-Versus-Host Disease: A
Post Hoc Analysis of the Phase 3 REACH2 and REACH3 Studies
(Session: Immunodermatology & Blistering Disorders.)
Vitiligo
Total Vitiligo Area Scoring Index Response Maintenance or
Shift During 52 Weeks of Ruxolitinib Cream Treatment for Vitiligo:
Pooled Analysis of the TRuE-V Phase 3 Studies (Abstract #43938.
Session: Pigmentary Disorders & Vitiligo.)
Treatment-Emergent Adverse Events of Interest for Janus
Kinase Inhibitors: Pooled Analysis of the 52-Week TRuE-V Phase 3
Studies of Ruxolitinib Cream Treatment for Vitiligo (Abstract
#43978. Session: Pigmentary Disorders & Vitiligo.)
Understanding the Patient Perspective in Living with and
Treating Vitiligo (Abstract #43040. Session: Pigmentary
Disorders & Vitiligo.)
More information regarding the 2023 AAD Annual Meeting can be
found at https://www.aad.org/member/meetings-education/am23.
In-Person Event and Webcast
Incyte will host an in-person analyst and investor event on
Saturday, March 18, 2023, from 5:30-7:30 p.m. CT, to discuss the
key vitiligo data presentations at AAD. The event will be webcasted
and can be accessed via the Events and Presentations tab of the
Investor section of Incyte.com and it will be available for replay
for 90 days.
Conference call details will be provided on our website.
About Opzelura® (ruxolitinib) Cream
Opzelura® (ruxolitinib) cream, a novel cream formulation of
Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the
U.S. Food & Drug Administration for the topical treatment of
nonsegmental vitiligo in patients 12 years of age and older, is the
first and only treatment for repigmentation approved for use in the
United States. Opzelura is also approved in the U.S. 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.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura. In April 2022, Incyte entered into a strategic
alliance agreement with Maruho Co., Ltd. for the development,
manufacturing and exclusive commercialization of ruxolitinib cream
for treatment of autoimmune and inflammatory dermatology
indications in Japan.
Opzelura is a registered trademark of Incyte.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 2 clinical trials for hidradenitis
suppurativa (HS), vitiligo and prurigo nodularis. A Phase 3 study
in HS is also ongoing.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of polycythemia vera (PV) in adults who have
had an inadequate response to or are intolerant of hydroxyurea;
intermediate or high-risk myelofibrosis (MF), including primary MF,
post-polycythemia vera MF and post-essential thrombocythemia MF in
adults; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older.1
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. Today, we are building on
this legacy as we discover and develop innovative dermatology
treatments to bring solutions to patients in need.
Our research and development efforts in dermatology are
initially focused on leveraging our knowledge of the JAK-STAT
pathway. We are exploring the potential of JAK inhibition for a
number of immune-mediated dermatologic conditions with a high unmet
medical need, including atopic dermatitis, vitiligo, lichen planus,
lichen sclerosus and prurigo nodularis.
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 dermatology portfolio, the presentation of
clinical data for that portfolio, whether or when any products,
development compounds, or combinations in that portfolio will be
approved or commercially available for use in humans anywhere in
the world (beyond those products already approved for certain
indications in specific regions), whether and when approved
products from Incyte’s dermatology portfolio will provide
successful treatment options for dermatology patients, along with
Incyte’s goal of improving the lives of patients, contain
predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’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 Incyte and its partners’ clinical trials, supply chain,
other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of Incyte and its partners’ products; the acceptance of
Incyte and its partners’ products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report for the year ended December 31, 2022.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
________________ 1 Jakafi (ruxolitinib) tablets: Prescribing
Information. U.S. Food and Drug Administration
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version on businesswire.com: https://www.businesswire.com/news/home/20230306005672/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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