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Randomized phase 2 trial met primary and secondary endpoints after 16 weeks of treatment in all treatment arms, reinforcing povolcitinib's potential role in the treatment of prurigo nodularis (PN)
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Results presented in the latest oral presentation at the American Academy of Dermatology (AAD) Annual Meeting mark Incyte's first data presentation in PN
Wilmington, Delaware, March 10, 2024–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today evaluates the efficacy and safety of povolcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN). The results of the phase 2 trial were announced. These data were presented in an updated oral presentation (Session: S050 – Latest Research: Session 2) at the American Academy of Dermatology (AAD) Annual Meeting, March 8-12, 2024 in San Diego. Ta.
The study met its primary endpoint with significantly more patients (36.1%) receiving povolcitinib across all treatment groups improving their Numerical Pruritus Rating Scale (NRS4) scores by 4 or more points. [P<0.01],44.4% [P<0.001],54.1% [P<0.0001] Median time to NRS4 with pruritus was 58, 35, and 17 days for patients receiving 15, 45, and 75 mg povolcitinib, respectively, compared to patients receiving placebo (8.1%) at week 16. was. It could not be estimated in the placebo group.
“PN is a condition that can cause itchy bumps on the skin called nodules that appear after excessive scratching. “There remains a significant need for effective treatments,” said Kurt Brown, M.D., Vice President and Head of Povolcitinib Global Program at Insight. “These Phase 2 results, particularly the improved itch resolution demonstrated after just four weeks of treatment, are promising for patients around the world living with this disease. We are excited to expand into this new potential indication.”
Secondary endpoints of the study were also met. At Week 16, 13.9%, 30.6%, and 48.6% of patients receiving 15 mg, 45 mg, and 75 mg of povolcitinib had an Investigator Global Assessment of Treatment Success (IGA-TS) score of 0 or 1, grade 2 or higher. Achieved. improvement from baseline compared to 5.4% of patients receiving placebo. Additionally, 8.3%, 22.2%, and 35.1% of patients receiving 15 mg, 45 mg, and 75 mg of povolcitinib achieved both itch NRS4 and IGA-TS at week 16, respectively, compared with placebo. and 2.5% in patients who received .
Povolcitinib was generally well tolerated, and the safety profile was consistent with previously reported data. The most common treatment-emergent adverse events (TEAEs) in patients receiving povolcitinib were headache (11.1%), fatigue (9.3%), and nasopharyngitis (7.4%). Grade 3 or higher TEAEs and serious TEAEs occurred in 4 (3.7%) and 9 (8.3%) patients treated with povolcitinib, and discontinuation due to AEs was rare (povolcitinib, n=5) [4.6%]; Placebo, n=1 [2.7%]).
“PN is often difficult to treat because uncontrollable itching and scratching can lead to the growth of nodules that appear on the patient's skin,” says Martin, professor of dermatology and allergy at Charité University.・Dr. Metz said. “Breaking the itch and scratch cycle is essential when treating patients with PN, and we are encouraged by these results showing improvement in itch and skin clearance by week 16. Our results show promise for povolcitinib as a potential new treatment option for patients with cancer.”
More information about the 2024 AAD Annual Meeting can be found at https://www.aad.org/member/meetings-education/am24.
About prurigo nodularis
Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by intense itching and thickened red bumps on the arms, legs, and torso.1 As a result of persistent and intense scratching and rubbing of the skin, PN causes itchy bumps called “nodules” on the skin.2 PN seems to be more common in older adults, and the painful bumps and constant itching can have a major impact on a patient's sleep and overall quality of life.1
About Phase 2 study (NCT05061693)
This randomized, double-blind, placebo-controlled, phase 2 clinical trial evaluated the safety and efficacy of povolcitinib (INCB54707) over 16 weeks, followed by 24 weeks in adult patients with prurigo nodularis (PN). Designed for extended evaluation. This study consisted of 146 adult patients (age 18 years and older) diagnosed with PN who had an inadequate response or were unable to tolerate previous PN treatment.
The study's primary endpoint was the proportion of participants whose Numerical Pruritus Rating Scale (NRS) score improved by 4 points or more over 16 weeks. Secondary endpoints included the proportion of participants who achieved Investigator-Assessed Global Treatment Success (IGA-TS) at week 16, and the proportion of participants who achieved Investigator-Assessed Global Treatment Success (IGA-TS) from baseline to IGA-TS and itch NRS scores assessed by week 16. Includes the proportion of patients who achieved both improvements of 4 points or more. Number of participants who experienced treatment-emergent adverse events (TEAEs) (assessed by week 16).
For more information about the study, visit https://classic.clinicaltrials.gov/ct2/show/NCT05061693.
About povolcitinib (INCB54707)
Povolcitinib (INCB54707) is an oral small molecule JAK1 inhibitor currently in phase 3 clinical trials for hidradenitis suppurativa (HS) and vitiligo. A phase 3 trial is planned for prurigo nodularis (PN). Phase 2 trials of povolcitinib in PN, asthma, and chronic spontaneous urticaria are also ongoing.
About Insight Dermatology
Incyte's science-first approach and expertise in immunology form the foundation of the company. Today, we build on this tradition by discovering and developing innovative dermatological treatments and providing solutions to patients in need.
Our research and development efforts in dermatology initially focused on leveraging our knowledge of the JAK-STAT pathway. We demonstrate the potential of JAK inhibition for many immune-mediated skin diseases with high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus, and prurigo nodularis. I'm researching sex.
For more information, please visit the Dermatology section of Incyte.com.
About Insight
A global biopharmaceutical company with a mission of Solved., Insight follows science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of unique therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong product pipeline in oncology, inflammation and autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia. For more information about Incyte, visit Incyte.com or follow us on social media: LinkedIn; XInstagram, Facebook, and YouTube.
Incyte's forward-looking statements
Other than the historical information contained herein, matters contained in this press release include statements regarding the presentation of data from Incyte's clinical development pipeline and the availability of povolcitinib for human use anywhere in the world. It includes statements as to whether, when, and when it will be approved or made commercially available. His Incyte's goal of improving the lives of patients includes 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 could cause actual results to differ materially. This includes the following unforeseen developments and related risks: Results of further research and development and clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or may not warrant continued development. the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects according to planned schedules; decisions made by the FDA and regulatory authorities outside the United States; the effectiveness or safety of our products; market acceptance of our products; market competition. unanticipated fluctuations in demand for our products and the products of our affiliate partners; the impact of announced or unanticipated price regulations or limitations on refunds or compensation for our products; sales, marketing, manufacturing and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and additional new products that are approved; and other risks detailed from time to time in our reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended December 31, 2023. The Company disclaims any intention or obligation to update these forward-looking statements. comment.
1 National Organization for Rare Diseases. Prurigo nodularis. https://rarediseases.org/rarediseases/prurigo-nodularis/. Accessed February 7, 2024.
2 Yale Medicine. Prurigo nodularis. https://www.yalemedicine.org/conditions/prurigo-nodularis-overview. Accessed February 7, 2024.
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