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Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata
NektarNektar(US:NKTR) Prnewswireยท2025-07-29 13:00

Core Insights - Nektar Therapeutics announced that the FDA granted Fast Track designation for rezpegaldesleukin, aimed at treating severe-to-very severe alopecia areata in adults and pediatric patients aged 12 and older [1][6] - Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex to stimulate regulatory T cells, showing safe and dose-dependent increases in Tregs in clinical trials [1][5] - The company is on track to announce topline data from the REZOLVE-AA Phase 2b study in December 2025, which evaluates the efficacy of rezpegaldesleukin in alopecia areata [1][2] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases, with rezpegaldesleukin as its lead product candidate [9] - The company is also evaluating other therapeutic candidates, including a preclinical bivalent TNFR2 antibody and bispecific programs, as well as NKTR-255, an investigational IL-15 receptor agonist for cancer [9] Study Details - The REZOLVE-AA study enrolled approximately 90 patients with severe-to-very severe alopecia areata, randomized to receive either rezpegaldesleukin or placebo [2][4] - The primary efficacy endpoint is the mean percent change in the Severity of Alopecia Tool (SALT) score after a 36-week induction period, with secondary endpoints assessing the proportion of participants achieving significant reductions in SALT scores [2][4] Disease Context - Alopecia areata is an autoimmune disease characterized by hair loss, affecting about 6.7 million people in the U.S. and 160 million worldwide, with a lifetime incidence of 2% [8] - Current therapies for alopecia areata are not durable and have high relapse rates, indicating a significant unmet medical need for more effective treatments [8]