Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress…

WILMINGTON, Del., September 13, 2021--(BUSINESS WIRE)--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 years 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

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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 Incytes 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

Incytes science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Companys 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 Incytes 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 Incytes Dermatology program generally, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Companys 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 Companys 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 Companys products; the acceptance of the Companys products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Companys 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005816/en/

Contacts

Media Catalina Loveman+1 302 498 6171cloveman@incyte.com

Jenifer Antonacci+1 302 498 7036jantonacci@incyte.com

Investors Christine Chiou+1 302 274 4773cchiou@incyte.com

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Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress...