Drugs

Nektar Reports Favorable Data in Alopecia Areata Study

Nektar Therapeutics is reporting new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth among patients with severe-to-very-severe Alopecia areata treated with its investigational therapy rezpegaldesleukin.

The results come from a 16-week blinded extension of the Phase 2b study, in which patients who initially responded to treatment continued receiving twice-monthly injections through one year, the company says, adding that the data demonstrate “deepening responses” over time, supporting advancement into late-stage development.

Nektar says that among patients who continued therapy beyond the initial 36-week period, 29% in the lower-dose group and 31% in the higher-dose group newly achieved a Severity of Alopecia Tool (SALT) score of 20 or less between weeks 36 and 52 — a benchmark indicating at least 80% scalp hair coverage. No patients in the placebo arm reached that threshold during the same period.

Across the full study population, response rates also improved over time. By week 52, roughly 26% to 28% of patients receiving rezpegaldesleukin achieved a SALT score less than 20, compared with about 7% in the placebo group. Higher proportions of treated patients also reached other clinically meaningful thresholds, including 50% or greater improvement in hair regrowth, it says.

Rezpegaldesleukin is described as a first-in-class interleukin-2 pathway agonist that stimulates regulatory T cells, offering a different approach from currently approved JAK inhibitors. Clinicians involved in the study said the data suggest the therapy could emerge as a new systemic option, particularly given safety and durability considerations associated with existing treatments, according to Nektar.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome