- Two late-breaking abstracts have been accepted for oral
presentation, including randomized studies evaluating ruxolitinib
cream (Opzelura®) in hidradenitis suppurativa and povorcitinib
(INCB54707) in prurigo nodularis
- Analyst and investor event to discuss key data presentations
scheduled for Monday, March 11, 2024 at 9:00 a.m. PT / 12:00 p.m.
ET
Incyte (Nasdaq:INCY) today announced multiple abstracts
featuring data from its dermatology portfolio will be presented at
the upcoming 2024 American Academy of Dermatology (AAD) Annual
Meeting, held March 8-12, 2024, in San Diego.
“We are pleased to convene at this year’s AAD Annual Meeting and
share data, including two late-breaking presentations, from our
growing dermatology portfolio,” said Jim Lee, M.D., Ph.D., Group
Vice President, Inflammation & Autoimmunity, Incyte. “Our
presence at this year’s meeting showcases Incyte’s commitment to
find solutions for patients where there continues to be critical
unmet needs. We are excited to share clinical data evaluating
ruxolitinib cream and povorcitinib in immune-mediated dermatologic
conditions including atopic dermatitis, vitiligo, hidradenitis
suppurativa and prurigo nodularis.”
Key abstracts include:
Late-Breaking Oral
Presentations
Prurigo Nodularis
Efficacy and Safety of Povorcitinib in Patients with Prurigo
Nodularis: Results From a Randomized, Double-Blind,
Placebo-Controlled Phase 2 Study (Session: S050 – Late-Breaking
Research: Session 2. Sunday, March 10, 2024, 4:00 p.m. ET)
Hidradenitis Suppurativa
Efficacy and Safety of Ruxolitinib Cream in Patients With
Hidradenitis Suppurativa (Hurley Stage I and II): Results From a
Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study
(Session: S050 – Late-Breaking Research: Session 2. Sunday, March
10, 2024, 4:10 p.m. ET)
e-Posters with Mini Oral
Presentation
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic
Dermatitis in Children Aged 2–<12 Years by Previous Medication
History: Subgroup Analysis from the Randomized Phase 3 TRuE-AD3
Study (Abstract: #54214. Friday, March 8, 2024, 4:10 – 4:15
p.m. ET. Upper Level, Sails Pavilion, Poster Center 2)
e-Poster Exhibits
Atopic Dermatitis
Effect of Ruxolitinib Cream on Patient-Reported Outcomes
(PROs) in Children Aged 2–<12 Years with Atopic Dermatitis (AD):
Results from a Randomized, Double-Blind, Vehicle-Controlled, Phase
3 Study (TruE-AD3) (Abstract: #49439)
Atopic Dermatitis (AD) Treatments Before and After Initiation
of Ruxolitinib Cream: Analysis of a US Payer Claims Database
(Abstract: #53102)
Real-World Clinical Experience with Ruxolitinib Cream
Monotherapy to Manage Atopic Dermatitis (Abstract: #53107)
A Maximum-Use Trial of Ruxolitinib Cream in Children ≥2 to
<12 Years Old with Atopic Dermatitis (AD): Patient-Reported
Outcomes (PROs) at Week 8 (Abstract: #54025)
Efficacy of Ruxolitinib Cream for Treatment of Atopic
Dermatitis in Children Aged 2–<12 Years by Baseline Clinical
Characteristics: Subgroup Analysis from a Randomized Phase 3 Study
(TRuE-AD3) (Abstract: #54147)
Maximum-Use Trials of Ruxolitinib Cream in Adults,
Adolescents, and Children Aged 2 to <12 Years with Atopic
Dermatitis: Consistency of Safety, Pharmacokinetics, and
Efficacy (Abstract: #54168)
Vitiligo
Serum Protein Biomarkers May Reveal Clues to Early Immune
Activity Upon Ruxolitinib Cream Withdrawal in the TRuE-V Long-Term
Extension Study (Abstract: #50342)
Efficacy of Povorcitinib for the Treatment of Vitiligo by
Patient Demographics and Baseline Clinical Characteristics: Week 52
Subgroup Analysis from a Randomized, Placebo-Controlled, Phase 2b
Clinical Trial (Abstract: #53962)
Correlation of Vitiligo Area Scoring Index with Vitiligo
Extent Score-Plus Responses in a Randomized, Double-Blinded,
Placebo-Controlled, Dose-Ranging Phase 2b Study (Abstract:
#53971)
All 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 2024.
More information regarding the 2024 AAD Annual Meeting can be
found at https://www.aad.org/member/meetings-education/am24.
Conference Call and Webcast
Incyte will host an in-person analyst and investor event on
Monday, March 11, 2024, from 9:00-10:30 a.m. PT (12:00-1:30 p.m.
ET) to discuss the key 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 30 days.
Conference call details will be provided on our website.
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is 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.
In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for
the treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States and Europe as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1
inhibitor currently in Phase 2 clinical trials for vitiligo,
hidradenitis suppurativa (HS) and prurigo nodularis. Phase 3
studies in HS are also ongoing.
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, hidradenitis
suppurativa, lichen planus, lichen sclerosus and prurigo
nodularis.
To learn more, visit the Dermatology section of Incyte.com.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia. For additional
information on Incyte, please visit Incyte.com or follow us on
social media: LinkedIn, X, Instagram, Facebook, YouTube.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the presentation of data from Incyte’s clinical
development pipeline, whether or when any development compounds or
combinations will be approved or commercially available for use in
humans anywhere in the world outside of the already approved
indications in specific regions, and 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;
determinations made by the FDA, EMA, and other regulatory
authorities; 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, 2023. Incyte disclaims any intent or
obligation to update these forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240304329736/en/
Media media@incyte.com
Investors ir@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Sep 2023 to Sep 2024