Press Release

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 25, 2024-- Incyte (Nasdaq:INCY) today announced that key data from across its dermatology portfolio, including multiple late-breaking abstracts, will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2024 held September 25-28 in Amsterdam.

“We’re excited to present five late-breaking oral presentations at this year’s congress, featuring data that could further expand treatment options for those living with immune-mediated dermatologic conditions, including vitiligo, atopic dermatitis, hidradenitis suppurativa and prurigo nodularis,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “The data highlight our ongoing efforts to evaluate the efficacy and safety of ruxolitinib cream in new patient populations, as well as deepen our understanding of povorcitinib in patients impacted by debilitating immune-mediated dermatologic conditions.”

Key abstracts from Incyte-sponsored programs include:

Late-breaking Oral Presentations

Vitiligo

Impact of Treatment Duration on Response Durability: A Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo
Abstract #8077. Session: D2T01.3: Late breaking news. Presentation Time: 9:15 – 9:30 a.m. ET (3:15 – 3:30 p.m. CET), September 26, 2024

Atopic Dermatitis

52-Week Safety and Disease Control With Ruxolitinib Cream in Children Aged 2 to 11 Years With Atopic Dermatitis: Results From the Phase 3 TRuE-AD3 Study
Abstract #8082. Session: D2T01.4: Late breaking news. Presentation Time: 10:00 – 10:15 a.m. ET (4:00 – 4:15 p.m. CET), September 26, 2024

Hidradenitis Suppurativa

Ruxolitinib Cream for Mild-to-Moderate Hidradenitis Suppurativa: 32-Week Data From a Randomized Phase 2 Study
Abstract #8071. Session: D2T01.3: Late breaking news. Presentation Time: 9:00 – 9:15 p.m. ET (3:00 – 3:15 p.m. CET), September 26, 2024

Prurigo Nodularis

Efficacy and Safety of Oral Povorcitinib in Patients With Prurigo Nodularis: 40-Week Results From a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Abstract #8081. Session: D2T01.3: Late breaking news. Presentation Time: 9:30 – 9:45 a.m. ET (3:30 – 3:45 p.m. CET), September 26, 2024

Lichen Planus

Efficacy and Safety of Ruxolitinib Cream in Patients With Cutaneous Lichen Planus: Results From a Phase 2, Randomized, Vehicle-Controlled Study
Abstract #7974. Session: D3T01.4: Late breaking news. Presentation Time: 10:30 – 10:45 a.m. ET (4:30 – 4:45 p.m. CET), September 27, 2024

ePosters

Vitiligo

Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo Through 2 Years in the TRuE-V Studies
Poster #P2983.

Characterizing Maintenance of Repigmentation in a Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo
Poster #P2984.

Effect of Povorcitinib on Achievement of VASI50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study
Poster #P3016.

Effect of Povorcitinib on Achievement of VESplus50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study
Poster #P3017.

Full session details and data presentation listings, please see the EADV 2024 Congress online program here: https://eadvapps.m-anage.com/eadvcongress2024/en-GB/pag/

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 and Europe 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 3 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

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, the promise presented by that 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 our current expectations and are 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; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.

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Source: Incyte