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

Rhea-AI Summary

Incyte announced that data from the Phase 3 TRuE-V program of ruxolitinib cream for treating vitiligo will be presented during a late-breaking oral presentation at the EADV 30th Anniversary Congress from September 29 to October 2, 2021. Both TRuE-V1 and TRuE-V2 studies met primary and key secondary endpoints. The highlights include safety and efficacy results for ruxolitinib cream, which shows potential as an effective treatment for patients with vitiligo and atopic dermatitis. This development underscores Incyte's commitment to addressing unmet medical needs in dermatology.

Positive

• Data from Phase 3 TRuE-V program shows ruxolitinib cream met primary and key secondary endpoints.
• Presentation at EADV congress showcases commitment to dermatology and treatment advancements.

Negative

• None.

• 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

WILMINGTON, Del.--(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 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.

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

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

Source: Incyte

FAQ

What is the significance of the Phase 3 TRuE-V program results for ruxolitinib cream?

The Phase 3 TRuE-V program results indicate that ruxolitinib cream has met primary and secondary endpoints, showcasing its potential effectiveness for treating vitiligo.

When will Incyte present the TRuE-V program data?

Incyte will present the TRuE-V program data during a late-breaking oral presentation at the EADV congress on October 2, 2021.

What conditions is ruxolitinib cream being developed to treat?

Ruxolitinib cream is being developed for the treatment of vitiligo and atopic dermatitis.

Where can I find more information about the EADV congress?

More information about the EADV congress is available on their official website: https://www.eadvcongress2021.org/

What is Incyte's focus in dermatology?

Incyte focuses on developing therapies targeting immune-mediated dermatologic conditions with high unmet medical needs, including atopic dermatitis and vitiligo.