Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress
September 13 2021 - 4:30PM
Business Wire
- Data from the Phase 3 TRuE-V program of ruxolitinib cream in
vitiligo to be presented for the first time in a late-breaking oral
presentation
Incyte (Nasdaq:INCY) today announced that multiple abstracts
highlighting data for ruxolitinib cream, an investigational topical
JAK1/JAK2 inhibitor, in patients with vitiligo and atopic
dermatitis (AD) will be presented at the upcoming European Academy
of Dermatology and Venereology (EADV) 30th Anniversary Congress,
held virtually from September 29-October 2, 2021.
The 24-week data from the Phase 3 TRuE-V program evaluating the
safety and efficacy of ruxolitinib cream in adolescent and adult
patients (age ≥12 years) with vitiligo will be presented as a
late-breaking oral presentation. Incyte previously announced that
both the TRuE-V1 and TRuE-V2 studies met the primary and key
secondary endpoints.
“We look forward to sharing data demonstrating the potential of
ruxolitinib cream as an effective treatment option for patients
living with vitiligo with the dermatology community at this year’s
EADV virtual congress,” said Jim Lee, M.D., Ph.D., Group Vice
President, Inflammation & Autoimmunity, Incyte. “These data
from the Phase 3 TRuE-V program underscore our commitment to
bringing new therapies to patients with challenging skin
diseases.”
Key abstracts include:
Late-Breaking Oral
Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of
Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3
Studies (Abstract #D3T01.2A. Session: Late Breaking News.
Saturday, October 2, 5:15-6:15 a.m. ET)
Oral Presentation
Atopic Dermatitis
Efficacy and Safety of Ruxolitinib Cream among Patients Aged
≥65 Years with Atopic Dermatitis: Pooled Results from Two Phase 3
Studies (Abstract #FC01.01. Session: Atopic dermatitis/Eczema.
Thursday, September 30, 4:00-4:10 a.m. ET)
Poster Presentations
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic
Dermatitis by Baseline Clinical Characteristics (encore)
(Abstract #P0187. Session: Atopic dermatitis/Eczema)
Efficacy of Ruxolitinib Cream among Patients with Atopic
Dermatitis Based on Previous Medication History (encore)
(Abstract #P0192. Session: Atopic dermatitis/Eczema)
Effects of Ruxolitinib Cream in Patients with Atopic
Dermatitis with Baseline Body Surface Area ≥10% and Eczema Area and
Severity Index Score ≥16 (encore) (Abstract #P0190. Session:
Atopic dermatitis/Eczema)
Patient-Reported Outcomes of Ruxolitinib Cream for the
Treatment of Atopic Dermatitis (encore) (Abstract #P0188.
Session: Atopic dermatitis/Eczema)
More information regarding the virtual conference is available
on the EADV website: https://www.eadvcongress2021.org/. Following
the conference, all e-Posters will be made available online on
http://www.eadv.org for EADV members.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s
selective JAK1/JAK2 inhibitor ruxolitinib that has been designed
for topical application. Ruxolitinib cream is currently in Phase 3
development for the treatment of adolescents and adults with atopic
dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide
rights for the development and commercialization of ruxolitinib
cream.
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 atopic dermatitis, 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
or atopic dermatitis (AD), the potential for success of such
treatment, 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 U.S. FDA and other
regulatory authorities outside of the United States; 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.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci +1 302 498 7036 jantonacci@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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