Nemolizumab for Atopic Dermatitis Shows Positive Results in Phase 3 Trials
Galderma said the FDA has accepted the company’s Biologics License Application for the therapy based on data from the trials.
Positive results from 2 phase 3 clinical trials evaluating the efficacy and safety of nemolizumab in adolescent and adult patients with moderate to severe atopic dermatitis have recently been announced, according to a press release from pharmaceutical company Galderma.1
Nemolizumab for Atopic Dermatitis Shows Positive Results in Phase 3 Trials / Марина Терехова - stock.adobe.com
Results from the ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials showed that the therapy met the co-primary endpoints of an Investigator's Global Assessment (IGA) success score of 0 or 1 with a 2 or more point improvement from baseline at 16 weeks and at least 75% improvement in Eczema Area and Severity Index score. Nemolizumab also met its key secondary endpoints, including proportion of participants with Peak Pruritus Numerical Rating Scale (PP-NRS) score improvement of at least 4 points, PP-NRS score below 2, and Sleep Disturbance Numerical Rating Scale score improvement of at least 4 points.
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Data from the 2 clinical trials were detailed in a study published in The Lancet.2
“As a practicing dermatologist, I’m excited about the potential of nemolizumab for atopic dermatitis patients,” Jonathan Silverberg, lead investigator on the clinical trial program, said in a release.1 “These phase III data demonstrate that, by blocking the activity of IL-31, nemolizumab could effectively address itch, skin lesions and sleep disturbance. Many patients complain that chronic itch negatively impacts their overall quality of life. Reducing itch within just one week of treatment could significantly ease the burden of disease.”
The 2 clinical trials were identical 48-week randomized, double-blind, placebo-controlled phase 3 studies evaluating the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks compared to placebo in adult and adolescent participants aged 12 years or older with moderate to severe atopic dermatitis, associated pruritus, and inadequate response to topical steroids.
The study cohort included 1728 across both trials who were enrolled between August 2019 and November 2022. Of the patients, 1142 were in the nemolizumab plus topical corticosteroids with or without topical calcineurin inhibitors (TCS-TCI) group, and 586 were in the placebo plus TCS-TCI group. ARCADIA 1 included 500 men and 441 females, while ARCADIA 2 included 381 males and 406 females. The mean age ranged from 33 to 35 across both trials.
Investigators found that more patients in the nemolizumab plus TCS–TCI group had IGA success at 16 weeks compared to placebo. Patients receiving the therapy also had significantly improved skin lesions, itch as early as week 1, and sleep by week 16 compared to placebo. The safety profile was similar between groups, with most adverse events being mild to moderate in severity.
Galderma said in the release that the FDA has accepted the company’s Biologics License Application (BLA) for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis based on the data from the trials. A decision on the BLA is expected by the end of the year. The company also said that it is awaiting decisions from the European Medicines Agency, Health Canada, and the Access Consortiumon applications for both atopic dermatitis and prurigo nodularis.
“Publication of the phase III ARCADIA program results for the first time in The Lancet reinforces both the robustness of our trial design and the potential of nemolizumab as an effective treatment option for patients living with atopic dermatitis,” Baldo Scassellati Sforzolini, global head of R&D at Galderma, said in a release.1 “We are working closely with regulators in the U.S., Europe, and elsewhere to bring nemolizumab to those in need as soon as possible.”
READ MORE: Dermatology Resource Center
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References
1. Phase III Arcadia 1 and 2 trial primary results published in The Lancet: Galderma’s nemolizumab improves key aspects of atopic dermatitis – itch, skin lesions and sleep disturbance. News Release. Galderma. July 25, 2024. Accessed July 25, 2024. https://www.galderma.com/news/phase-iii-arcadia-1-and-2-trial-primary-results-published-lancet-galdermas-nemolizumab
2. Silverberg JI, Wollenberg A, Reich A, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. July 24, 2024. DOI:https://doi.org/10.1016/S0140-6736(24)01203-0
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