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Multiple Abstracts from Incyte’s Dermatology Portfolio Accepted for Presentation at the AAD Virtual Meeting Experience

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Incyte announced the presentation of multiple abstracts from its dermatology portfolio at the American Academy of Dermatology Virtual Meeting Experience from April 23-25, 2021. Key topics include new findings from the Phase 3 TRuE-AD clinical trial on ruxolitinib cream for atopic dermatitis and 104-week data from a Phase 2 study for vitiligo. The company aims to enhance understanding and treatment options for these chronic conditions, with a focus on the efficacy and safety of ruxolitinib cream.

Positive
  • Presentation of new data on ruxolitinib cream at major dermatology conference.
  • Phase 3 findings on the efficacy of ruxolitinib cream for atopic dermatitis show promise.
  • 104-week data from Phase 2 study on vitiligo indicates potential effectiveness.
Negative
  • None.

Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology Virtual Meeting Experience (AAD VMX), held virtually from April 23-25, 2021.

Presentations at AAD VMX will feature new findings on disease control and quality-of-life measures from the Phase 3 TRuE-AD clinical trial program evaluating the safety and efficacy of ruxolitinib cream in patients with atopic dermatitis (AD). Additionally, 104-week data from the Phase 2 study of ruxolitinib cream in patients with vitiligo will be featured, along with findings about the maintenance of repigmentation following treatment.

“We look forward to the opportunity to showcase additional data from our Phase 2 and Phase 3 studies of ruxolitinib cream, which provide further insights on the potential of this investigational therapy to become an important treatment option for patients living with AD and vitiligo,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “Chronic skin conditions like AD and vitiligo can be life-altering and have serious impacts, and we hope this research will advance the overall understanding of the needs of people living with these conditions as we seek to provide therapies that can offer meaningful improvements.”

Key abstracts from Incyte-sponsored studies include:

e-Posters with Oral Presentation

Vitiligo (Category: Pigmentary Disorders & Vitiligo)

Safety and Efficacy of Ruxolitinib Cream for the Treatment of Vitiligo: 104-Week Data from a Phase 2 Study (Abstract #27535)

Maintenance of Repigmentation After Discontinuation of Ruxolitinib Cream in Patients with Vitiligo (Abstract #27568)

e-Poster Presentations

Atopic Dermatitis (Category: Dermatitis, Atopic)

Efficacy and Safety of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #27633)

Effects of Ruxolitinib Cream in Patients with Atopic Dermatitis with Baseline Body Surface Area ≥10% and Eczema Area and Severity Index Score ≥16: Pooled Results from Two Phase 3 Studies (Abstract #27620)

Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Baseline Clinical Characteristics: Pooled Subgroup Analysis from Two Randomized Phase 3 Studies (Abstract #27716)

Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Baseline Patient Demographics: Pooled Subgroup Analysis from Two Randomized Phase 3 Studies (Abstract #27496)

Efficacy of Ruxolitinib Cream Among Patients with Atopic Dermatitis Based on Previous Medication History: Pooled Results from Two Phase 3 Studies (Abstract #27482)

Efficacy of Ruxolitinib Cream in Patients with Atopic Dermatitis Who Demonstrated Partial Responses: Pooled Analysis from Two Randomized Phase 3 Studies (Abstract #24916)

Ruxolitinib Cream Rapidly Decreases Pruritus in Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #26884)

Effects of Ruxolitinib Cream on Work Productivity and Activity Impairment in Patients with Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #28200)

Effect of Ruxolitinib Cream on Sleep Disturbance and Sleep Impairment: Pooled Analysis from Two Randomized Phase 3 Studies (Abstract #26887)

Patient-Reported Outcomes of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #28194)

Vitiligo (Category: Pigmentary Disorders & Vitiligo)

Addition of Narrow-Band Ultraviolet Light B Phototherapy to Ruxolitinib Cream in Patients with Vitiligo (Abstract #27636)

Correlation of the Vitiligo Area Scoring Index with Patient – and Physician-Reported Measures of Clinical Improvement in a Randomized, Double-Blind Phase 2 Study (Abstract #25486)

All presentations will be available on demand starting April 23, 2021, at 8 a.m. CT (9 a.m. ET), and can be accessed until July 12, 2021. Full session details and listings all presentations are available on the AAD VMX program: https://eposters.aad.org/categories.

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 atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with 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 the presentation of data from the Company’s ongoing clinical development program of ruxolitinib cream, its atopic dermatitis and vitiligo programs generally, and whether or when ruxolitinib cream will be approved or commercially available for use in humans in the U.S. or elsewhere 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 and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials supply chain and other third-party providers and development and discovery operations; determinations made by the U.S. FDA 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; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

FAQ

What will Incyte present at the AAD Virtual Meeting Experience?

Incyte will present abstracts highlighting data from its dermatology portfolio, particularly on ruxolitinib cream for atopic dermatitis and vitiligo.

When is the American Academy of Dermatology Virtual Meeting Experience?

The AAD Virtual Meeting Experience will be held from April 23-25, 2021.

What are the key findings from the TRuE-AD clinical trial?

The Phase 3 TRuE-AD clinical trial for ruxolitinib cream highlights new findings on disease control and quality-of-life measures for atopic dermatitis.

How long is the data from the vitiligo study?

The data presented from the Phase 2 study of ruxolitinib cream for vitiligo spans 104 weeks.

What is the focus of Incyte's dermatology research?

Incyte's dermatology research focuses on developing therapies that modulate immune pathways in chronic skin conditions like atopic dermatitis and vitiligo.

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