Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.

“We are pleased to add to the data supporting the use of ruxolitinib cream for patients living with vitiligo and atopic dermatitis (AD) through two late-breaking presentations – one on prolonged use of treatment in vitiligo patients with limited or no initial response, and the full results of our TRuE-AD3 trial in pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community."

Key abstracts from Incyte-sponsored programs include:

Late-breaking Oral Presentations

Vitiligo

Efficacy and Safety of Povorcitinib for Extensive Vitiligo: 52-Week Results from a Double-Blinded, Placebo-Controlled, Dose-Ranging Phase 2b Study (Abstract #6749. Session: D1T01.1A: Late Breaking News. Wednesday, October 11, 8:15 a.m. – 8:30 a.m. ET)

Efficacy of Prolonged Ruxolitinib Cream Treatment for Vitiligo Among Patients with Limited or No Initial Response at 6 Months (Abstract #6479. Session: D1T01.1I: Late Breaking News. Wednesday, October 11, 10:30 a.m. – 10:45 a.m. ET)

Atopic Dermatitis (AD)

A Phase 3 Study of Ruxolitinib Cream in Children Aged 2–<12 Years with Atopic Dermatitis (TRuE-AD3): 8-Week Analysis (Abstract #6746. Session: D3T01.3I: Late Breaking News. Friday, October 13, 10:30 a.m. – 10:45 a.m. ET)

Oral Presentations

Hidradenitis Suppurativa

Baseline Demographic and Disease Characteristics Associated with Achieving HiSCR with Povorcitinib: Secondary Analysis from a Phase 2, Randomized, Placebo-Controlled Clinical Trial (Abstract #2803. Session: FC02.1: Free Communications II. Thursday, October 12, 4:15 a.m. – 4:25 a.m. ET)

Impact of Povorcitinib on DLQI and DLQI Subdomains in Patients with Hidradenitis Suppurativa: Results from a Randomized, Placebo-Controlled Phase 2 Study (Abstract #2795. Session: FC02.2: Free Communications II. Thursday, October 12, 4:25 a.m. – 4:35 a.m. ET)

ePosters

Vitiligo

Effect of Ruxolitinib Cream on VASI-50 Achievement by Body Region Through Week 104 in Patients with Vitiligo: Analysis of the TRuE-V Long-Term Extension Phase 3 Study (Abstract #926)

Efficacy and Safety of Ruxolitinib Cream Through Week 104 in Patients with Vitiligo: Subgroup Analysis of the TRuE-V Long-Term Extension Phase 3 Study (Abstract #927)

Characterization and Treatment of Acne that Occurred Among Individuals with Vitiligo who Applied Ruxolitinib Cream in Two Randomized Phase 3 Trials (Abstract #2595)

Depression and Depressive Symptoms Among Persons Living with Vitiligo: Findings from the Global VALIANT Survey (Abstract #2572)

Treatment Satisfaction, Breaks and Cessation Among Patients Living with Vitiligo: Findings from the Global VALIANT Survey (Abstract #2579)

Retrospective Database Analysis on the Treatment Patterns in Patients with Vitiligo in Quebec, Canada (Abstract #2591)

Epidemiology and Comorbidity of Patients with Vitiligo in Germany (Abstract #3072)

AD

A Maximum-Use Trial of Ruxolitinib Cream in Children Aged ≥2 years to <12 Years with Atopic Dermatitis: 8-Week Analysis (Abstract #2551)

Rapid, Substantial and Sustained Reduction of Itch in Adults with Atopic Dermatitis Applying Ruxolitinib Cream — Clinical and Translational Results from the Open-Label Phase 2 SCRATCH-AD Study (Abstract #2813)

For full session details and data presentation listings, please see the EADV Congress 2023 (https://eadvcongress2023.org/scientific/) online program.

About Opzelura^® (ruxolitinib) Cream 1.5%

Opzelura, 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.

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 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), prurigo nodularis, chronic spontaneous urticaria and asthma. 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

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 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’s products; the acceptance of Incyte’s 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 and its quarterly report on Form 10-Q for the quarter ended September 30, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.

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