Rezpegaldesleukin Shows Broad EASI Efficacy, 28.2% SALT Reduction And Q2 2026 Phase 3 Start
Rezpegaldesleukin achieved statistically significant mean EASI score reductions across vIGA-AD® 3 and 4 subgroups in 393 moderate-to-severe atopic dermatitis patients, triggering a planned Phase 3 ZENITH-AD initiation in Q2 2026. In severe-to-very-severe alopecia areata, the 24 µg/kg dose delivered a 28.2% SALT score reduction versus 11.2% placebo at 36 weeks.
1. REZOLVE-AD Phase 2b Efficacy Results
In the global Phase 2b REZOLVE-AD study, 393 moderate-to-severe atopic dermatitis patients were randomized to three rezpegaldesleukin dosing regimens or placebo. Across baseline vIGA-AD® scores of 3 and 4, all treatment arms showed statistically significant mean EASI score reductions and comparable EASI-75 and EASI-90 response rates over a 16-week induction, consistent across geographic regions.
2. REZOLVE-AA Phase 2b SALT Reduction Data
In the Phase 2b REZOLVE-AA trial involving severe-to-very-severe alopecia areata patients, the high dose of 24 µg/kg q2w achieved a mean 28.2% reduction in SALT score at 36 weeks versus 11.2% for placebo, reaching statistical significance when excluding four ineligible patients. Rezpegaldesleukin was well tolerated, with a safety profile aligned with earlier findings.
3. Phase 3 ZENITH-AD Program Initiation
Based on the robust Phase 2b efficacy and safety outcomes, Nektar plans to initiate the global Phase 3 ZENITH-AD program in moderate-to-severe atopic dermatitis patients in Q2 2026, leveraging its regulatory T-cell expansion mechanism to potentially address multiple inflammatory pathways.