Nektar Therapeutics reports positive 52-week data for alopecia areata drug trial
Nektar Therapeutics (NASDAQ: NKTR) announced results from a 52-week study of its experimental drug rezpegaldesleukin in patients with severe-to-very-severe alopecia areata, according to a company statement.
The REZOLVE-AA Phase 2b study showed that 29% of patients receiving the 18 µg/kg dose and 31% of patients receiving the 24 µg/kg dose achieved new SALT Score ≤20 responses between weeks 36 and 52, compared to no patients in the placebo group. A SALT Score ≤20 indicates 80% or more scalp hair coverage.
At week 52, patients achieving SALT Score ≤20 were 25.8% in the low-dose group and 27.6% in the high-dose group, compared to 6.7% with placebo. The study enrolled 92 patients across approximately 30 sites globally, with mean baseline SALT scores of 78.5 in treatment arms versus 76.6 in placebo.
The treatment extension phase included 31 patients, with 27 receiving rezpegaldesleukin and 4 receiving placebo. The company reported that 94% of patients completed the 52-week treatment period.
"These extension treatment data to 52 weeks demonstrate the potential of rezpegaldesleukin to deliver truly meaningful clinical outcomes for patients with severe-to-very-severe alopecia areata," said David Rosmarin, Chair of the Department of Dermatology at Indiana University School of Medicine.
The most common side effects were injection site reactions, primarily mild to moderate erythema that resolved within five days. No patients discontinued treatment due to injection site reactions during the extension period.
Rezpegaldesleukin received Fast Track designation from the FDA in July 2025 for treating severe alopecia areata in adults and pediatric patients 12 years and older weighing at least 40 kg. The company plans to submit these results for presentation at a medical conference in 2026.