REZOLVE-AD Phase 2b Study of Rezpegaldesleukin Meets Primary and Key Secondary Endpoints in Patients with Moderate-to-Severe Atopic Dermatitis

Core Insights - Nektar Therapeutics announced statistically significant results from the Phase 2b REZOLVE-AD study of rezpegaldesleukin for atopic dermatitis, achieving primary and key secondary endpoints at week 16 [1][3][4] - The study demonstrated a rapid onset of Eczema Area and Severity Index (EASI) reduction and itch improvement, indicating the potential of rezpegaldesleukin as a first-in-class immune-modulator [1][7] - The safety profile of rezpegaldesleukin was consistent with previous reports, with the most common adverse events being mild to moderate injection site reactions [12][13] Study Design and Results - The global Phase 2b study involved 393 patients with moderate-to-severe atopic dermatitis, randomized to receive different dosing regimens of rezpegaldesleukin or placebo [2][18] - At week 16, the high dose (24 µg/kg every two weeks) showed a mean improvement in EASI score of 61%, while the middle and low doses showed improvements of 58% and 53%, respectively, all statistically significant compared to placebo [8][12] - Key secondary endpoints, including EASI-75 and EASI-90, also achieved statistical significance, with 42% and 25% of patients in the high dose group achieving these reductions, respectively [4][6] Efficacy and Biomarkers - The study revealed a robust dose-dependent reduction in inflammatory biomarkers associated with atopic dermatitis, including IL-19 and TARC/CCL17, with a notable increase in total regulatory T cells (Tregs) in the high dose group [9][10] - The results suggest that rezpegaldesleukin may offer a new therapeutic approach for treating dermatological diseases, with ongoing studies expected to provide further insights [9][10] Future Developments - Nektar plans to present the 16-week induction results at a medical conference later in 2025 and anticipates top-line data for alopecia areata in Q4 2025 [11][21] - The FDA granted Fast Track designation for rezpegaldesleukin for treating moderate-to-severe atopic dermatitis, indicating the potential for expedited development [21][22]