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REZOLVE-AD Phase 2b Study of Rezpegaldesleukin Meets Primary and Key Secondary Endpoints in Patients with Moderate-to-Severe Atopic Dermatitis
Achieved statistical significance on primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus
About this update from Nektar Therapeutics
[{"type":"text","content":"Achieved statistical significance on primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo\nAchieved statistical significance for key secondary endpoints at week 16 of disease reduction, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA\nRapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory T-cell mechanism as a first and best-in-class immune-modulator \nRobust dose-dependent reduction of inflammatory biomarkers in atopic dermatitis including TARC/CCL17, periostin, MDC/CCL22, and IL-19\nSafety profile consistent with previously reported results \nData expected in Q1 2026 from continued treatment of patients with atopic dermatitis in long-term maintenance part of REZOLVE-AD study \nTop-line Phase 2b data for rezpegaldesleukin in alopecia areata expected in Q4 2025\nConference call and webcast with management and atopic dermatitis experts today at 8:15 am ET / 5:15 am PT\nSAN FRANCISCO, June 24, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced statistically significant data from the 16-week induction period of the ongoing Phase 2b REZOLVE-AD study of investigational rezpegaldesleukin, an IL-pathway agonist and regulatory T-cell (Treg) proliferator.\n\n \n \n \n \n \n \n\n \nThe global Phase 2b study is being conducted in 393 patients with moderate-to-severe atopic dermatitis. Patients were randomized (3:3:3:2) to receive subcutaneous treatment with three doses of rezpegaldesleukin: a high dose of 24 µg/kg every two weeks (q2w), a middle dose of 18 µg/kg every two weeks (q2w), and a low dose of 24 µg/kg every four weeks (q4w), or placebo q2w. The primary endpoint and secondary endpoints were assessed at week 16. Following a 16-week induction period, rezpegaldesleukin-treated patients who achieved EASI percent score reductions of >50 were re-randomized (1:1) to continue at the same dose level on a q4w or q12w regimen through week 52 in a blinded maintenance period. Placebo patients with EASI percent score reductions of >50 percent continue to receive placebo q4w.\nRezpegaldesleukin Achieved Primary and Key Secondary Efficacy Endpoints at Week 16\nThe trial met its primary endpoi...