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Nektar Alopecia Trial Misses Endpoint, Hits Significance After Patient Exclusion
Benzinga· 2025-12-16 16:30
Core Insights - Nektar Therapeutics announced topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial for rezpegaldesleukin, targeting severe-to-very-severe alopecia areata [1] Study Results - The Phase 2b study involved 92 patients and assessed the mean percentage reduction in the Severity of Alopecia Tool (SALT) score at Week 36 as the primary endpoint [3] - Both dose arms of rezpegaldesleukin showed more than double the SALT score reduction compared to placebo, with mean percent reductions of 28.2% for the 24 µg/kg arm, 30.3% for the 18 µg/kg arm, and 11.2% for placebo, although the primary endpoint narrowly missed statistical significance [4] - At Week 36, the mean percent SALT reduction improved to 29.6% for 24 µg/kg and 30.4% for 18 µg/kg, with a significant difference from placebo at 5.7% [6] - The treatment arms demonstrated a dose-dependent clinical effect on key secondary endpoints, with options for patients showing hair growth to continue treatment for an additional 16 weeks [7] Future Plans - Nektar plans to present the REZOLVE-AA results at a medical conference in 2026, with additional data from the ongoing treatment extension expected in early Q2 2026 [8]