Nektar reports new results from Phase 2b REZOLVE-AA study

Nektar (NKTR) Therapeutics announced new results from a blinded 16-week treatment extension period in its Phase 2b REZOLVE-AA study. The study is evaluating investigational rezpegaldesleukin, a first-in-class IL-2 pathway agonist and regulatory T-cell, or Treg, biologic, in patients with severe-to-very-severe alopecia areata. REZOLVE-AA is a global study being conducted in 92 patients with severe-to-very-severe alopecia areata. During the initial 36-week induction phase, patients were randomized to receive one of two rezpegaldesleukin doses or placebo, administered as twice-monthly subcutaneous injections. Mean baseline Severity of Alopecia Tool, or SALT, Scores for patients enrolled in the study were 78.5 in the rezpegaldesleukin treatment arms as compared to 76.6 in placebo. Median time from onset of disease was 6.9 years in the treatment arms and 6.1 years in placebo. Following completion of the induction phase, patients with a SALT Score greater than 20 at week 36 who also demonstrated hair growth were eligible to continue on rezpegaldesleukin at their induction dose level in a blinded 16-week exploratory treatment extension through week 52. A total of 31 patients continued into the blinded 16-week treatment extension period with 27 patients in the twice-monthly rezpegaldesleukin dose arms and and 4 patients continuing in the placebo arm. From week 36 to week 52, 29% of patients at low dose and 31% of patients at high dose achieved new SALT Score less than or equal to20 responses as compared to none in the placebo arm. A SALT Score less than or equal to20 is achieved when a patient has 80% or more of their scalp covered by hair. At week 52 for overall study population, patients who achieved SALT Score less than or equal to20 were 25.8% in low dose rezpegaldesleukin arm and 27.6% in high dose rezpegaldesleukin arm (versus 15.6% at week 362) as compared to 6.7% with placebo with a p-value of 0.049.3 Nektar plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026.