Incyte to Unveil New Data from its Dermatology Portfolio at 2025 American Academy of Dermatology (AAD) Annual Meeting

Rhea-AI Summary

Incyte (NASDAQ: INCY) announces multiple data presentations at the upcoming 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, March 7-11, 2025. The presentations will feature new data from their dermatology portfolio, including:

- Late-breaking Phase 3 data for ruxolitinib cream (Opzelura®) in prurigo nodularis from the TRuE-PN1 study

- Multiple presentations on ruxolitinib cream in atopic dermatitis, including long-term safety data from TRuE-AD1 and TRuE-AD2 Phase 3 studies, treatment patterns, and 52-week disease control in children aged 2-11 years

- Data for axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD)

Positive

• Multiple Phase 3 clinical trial data presentations across different indications
• Expanding therapeutic applications for ruxolitinib cream
• Long-term safety and efficacy data available for key products
• Positive treatment effects in pediatric population

Negative

• None.

Insights

Biotechnology Research Analyst

Incyte's upcoming data releases at the AAD Annual Meeting represent significant clinical development progress for their dermatology portfolio. The late-breaking Phase 3 data for ruxolitinib cream (Opzelura®) in prurigo nodularis is particularly noteworthy as it could support label expansion beyond its current approvals in atopic dermatitis and vitiligo.

The multiple presentations on Opzelura in atopic dermatitis highlight Incyte's strategic focus on long-term safety data and real-world treatment patterns, important for commercial adoption by dermatologists. Of particular interest is data showing reduced use of other treatments following Opzelura initiation, which could strengthen its positioning against competitors in the crowded atopic dermatitis market.

The inclusion of axatilimab (Niktimvo™) data in patients with dermatologic manifestations of chronic GVHD demonstrates Incyte's continuing development of this recently approved therapy. Expanding clinical evidence in specific manifestations could help differentiate Niktimvo in the specialized GVHD treatment landscape.

This broad data presentation across multiple dermatological conditions reinforces Incyte's commitment to expanding its inflammation and immunology franchise, which has become increasingly important as the company works to diversify beyond its historical focus on oncology and hematology.

Medical Dermatology Specialist

The upcoming presentation of Phase 3 TRuE-PN1 trial results for ruxolitinib cream in prurigo nodularis represents a potential therapeutic breakthrough for a challenging condition with treatment options. PN causes intensely pruritic nodules and significantly impacts quality of life, with few FDA-approved therapies currently available.

Particularly important is the expanded pediatric data (ages 2-11) for Opzelura in atopic dermatitis, as treating younger populations requires special safety considerations. The 52-week data on as-needed application could support more flexible dosing regimens, addressing concerns about continuous topical JAK inhibitor use.

The abstract on reduction in use of other topical treatments, oral corticosteroids, and biologics following Opzelura initiation addresses a critical clinical question about therapeutic sequencing and potential steroid-sparing effects. If substantiated, this could influence treatment algorithms and position Opzelura earlier in the treatment paradigm.

For axatilimab, the post-hoc analysis in dermatologic manifestations of chronic GVHD is clinically relevant as skin involvement occurs in 80-90% of GVHD cases and significantly impacts patient morbidity. Dermatologists are increasingly involved in managing these complex patients, making this data particularly valuable for multidisciplinary care approaches.

- Featured abstracts for ruxolitinib cream (Opzelura^®) include multiple presentations in atopic dermatitis and late-breaking data in prurigo nodularis (PN)

- Pipeline data presented includes data for axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq: INCY) today announced that multiple abstracts featuring new data from its dermatology portfolio will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, being held March 7–11, 2025, in Orlando.

"We look forward to sharing new data for ruxolitinib cream (Opzelura^®) across multiple indications, including prurigo nodularis, and axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD) at this year's AAD Annual Meeting,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. "Incyte’s active participation in this key congress reinforces our commitment to addressing critical needs in dermatology while fostering meaningful dialogue with researchers, patients and advocates to inform the development of innovative treatments.”

Key abstracts include:

Late-Breaking Oral Presentation

Prurigo Nodularis (PN)

Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Results From a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1)
(Session: S028 – Late-Breaking Research: Session 1. Saturday, March 8, 2025, 9:24 a.m. ET)

ePoster Exhibits

Atopic Dermatitis (AD)

Long-Term Safety of Ruxolitinib Cream in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Adverse Events of Interest from the TRuE-AD1 and TRuE-AD2 Phase 3 Studies ​(Abstract: #64524)

Association of Ruxolitinib Cream Initiation with Reduction in Use of Other Topical Treatments, Oral Corticosteroids, and Biologics for Atopic Dermatitis, Regardless of Previous Use of Biologics​ ​(Abstract: #64526)

52-Week Disease Control and Safety with As-Needed Application of Ruxolitinib Cream in Children Aged 2 to 11 Years with Moderate and/or More Extensive Atopic Dermatitis: Subgroup Analysis from the TRuE-AD3 Study ​(Abstract: #64656)

Ruxolitinib Cream Demonstrated Long-Term Disease Control and Quality of Life Benefits in Adults and Adolescents with Mild to Moderate Atopic Dermatitis ​​(Abstract: #64727)

Graft-Versus-Host Disease (GVHD)

Axatilimab for Patients with Dermatologic Manifestations of Chronic Graft-Versus-Host Disease: A Post Hoc Analysis ​(Abstract: #64616)

More information regarding the 2025 AAD Annual Meeting can be found at: https://www.aad.org/member/meetings-education/am25.

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 Niktimvo™ (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

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 (PN), as well as Phase 2 trials for asthma and chronic spontaneous urticaria (CSU).

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, 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 and its partners’ products; the acceptance of Incyte and its partners’ 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 on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.

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FAQ

What new data will Incyte (INCY) present at the 2025 AAD Meeting for prurigo nodularis?

Incyte will present late-breaking Phase 3 data from the TRuE-PN1 study on the efficacy and safety of ruxolitinib cream in patients with prurigo nodularis.

What are the key findings for INCY's ruxolitinib cream in pediatric atopic dermatitis?

The TRuE-AD3 study shows 52-week disease control and safety data with as-needed application of ruxolitinib cream in children aged 2-11 years with moderate/extensive atopic dermatitis.

How does INCY's ruxolitinib cream affect the use of other treatments in atopic dermatitis?

Data shows ruxolitinib cream initiation is associated with reduced use of other topical treatments, oral corticosteroids, and biologics for atopic dermatitis.

What data will INCY present on axatilimab for GVHD at AAD 2025?

Incyte will present a post hoc analysis of axatilimab (Niktimvo) in patients with dermatologic manifestations of chronic graft-versus-host disease.