Nektar Therapeutics posts 52‑week REZOLVE‑AD: rezpegaldesleukin durability supports Phase 3 plan

Nektar posts sustained REZOLVE‑AD results at 52 weeks

Durable efficacy of rezpegaldesleukin validates Treg strategy and guides Phase 3

Nektar Therapeutics is reporting 52‑week blinded maintenance data from its global REZOLVE‑AD Phase 2b study of rezpegaldesleukin, a first‑in‑class regulatory T‑cell (Treg) biologic for moderate‑to‑severe atopic dermatitis. In the trial, 393 patients are randomized 3:3:3:2 to three induction doses or placebo for 16 weeks; responders achieving EASI‑50 are then re‑randomized 1:1 to continue the same induction dose monthly (Q4W) or quarterly (Q12W) through a 36‑week blinded maintenance period. The protocol includes a treatment‑escape arm for patients who do not reach EASI‑50 during induction, enabling assessment in a broader population.

The 24 µg/kg regimens show the strongest durability at week 52, with 71% of patients on Q4W and 83% on Q12W maintaining EASI‑75 responses. Investigator global assessment (vIGA‑AD) 0/1 is sustained in 85% of the monthly group and 63% of the quarterly group. Both dosing intervals also preserve higher‑level endpoints, including EASI‑90 and improvements on the Itch Numerical Rating Scale. Nektar reports meaningful deepening of responses over time, including up to a fivefold increase in complete skin clearance (EASI‑100): among re‑randomized patients, Q4W maintenance raises EASI‑100 from 4% after induction to 22% at week 52, with Q12W also delivering notable gains.

Safety through 52 weeks is described as favourable and consistent with prior rezpegaldesleukin data. Nektar frames the durability and deepening of responses as validating the Treg mechanism as a potential best‑in‑class immune modulator and says the blinded maintenance findings inform a planned pivotal Phase 3 programme that will evaluate both monthly and quarterly maintenance dosing strategies.

Funding to support continued development

Nektar is concurrently commencing an underwritten public offering of $300 million of common stock, with an underwriters’ 30‑day option for up to an additional $45 million. The company says net proceeds may fund research and development, clinical development including Phase 3 trials for rezpegaldesleukin, and manufacturing; the offering is subject to market and other conditions and lists Jefferies, TD Cowen and Piper Sandler as joint bookrunners.

Webcast details and next steps

Nektar is hosting a conference call and webcast today at 8:00 a.m. ET to discuss the 52‑week data and next steps for rezpegaldesleukin, including design considerations for the pivotal Phase 3 programme and the implications of the treatment‑escape arm for broader patient evaluation.