Nektar reports long-term rezpegaldesleukin data in atopic dermatitis and alopecia areata
Nektar said extended rezpeg treatment promoted greater hair growth in severe alopecia areata and reported durable 52-week efficacy for rezpegaldesleukin in atopic dermatitis. The company said it has FDA alignment on Phase 3 design and is targeting a BLA submission by 2029.
Nektar Therapeutics said extended treatment with rezpeg promoted greater hair growth in people with severe alopecia areata, and reported durable efficacy after 52 weeks of treatment with rezpegaldesleukin in moderate-to-severe atopic dermatitis. The company said it plans to advance rezpegaldesleukin into Phase 3 studies with a goal of submitting a Biologics License Application by 2029.
After one year, 27% of participants treated with either a low or high dose of rezpeg achieved a clinically meaningful hair-growth outcome, the company said. The response, formally known as SALT Score 20, is defined as 80% or more of the scalp covered by hair.
In the REZOLVE-AD Phase 2b study, 71% and 83% of patients maintained EASI-75 responses after 52 weeks of treatment with rezpegaldesleukin, indicating durable efficacy in moderate-to-severe atopic dermatitis patients. During the 36-week maintenance phase, some patients achieved new or deeper responses, with EASI-100 response rates showing up to a five-fold increase.
The company said the safety profile of rezpegaldesleukin remained consistent with earlier findings, with most adverse events being mild or moderate and low discontinuation rates across both dosing regimens. It also said it now has safety data on more than 1,000 Respag-treated patients, representing about 381 patient-years of exposure.
The company said it has secured alignment with the FDA on Phase 3 dosing and key trial design elements in atopic dermatitis. First patient randomization is targeted for June 2026, with the initial pivotal readout expected in mid-2028 and a potential biologics license application submission penciled in for 2029.