Nektar Therapeutics' rezpegaldesleukin shows durable 52‑week control, paves way for Phase 3

Rezpegaldesleukin shows durable control in REZOLVE‑AD, paving way for Phase 3

Nektar Therapeutics reports positive 52‑week results from its global REZOLVE‑AD Phase 2b study of rezpegaldesleukin, a regulatory T‑cell (Treg) biologic for moderate‑to‑severe atopic dermatitis. In the randomized trial, 393 patients are allocated 3:3:3:2 to three induction doses or placebo for a 16‑week induction, after which responders achieving EASI‑50 are re‑randomized 1:1 to continue the same induction dose either monthly (Q4W) or quarterly (Q12W) through a blinded 36‑week maintenance period. The study design also includes a treatment‑escape arm for patients who do not meet induction response, enabling assessment in a broader population.

Durability of response is strongest with the 24 µg/kg dose, where both Q4W and Q12W maintenance regimens sustain high rates of clinical benefit at week 52. Nektar reports that 71% of patients on the 24 µg/kg Q4W regimen and 83% on Q12W maintain EASI‑75 responses; vIGA‑AD 0/1 responses are maintained in 85% (Q4W) and 63% (Q12W). Both regimens also sustain EASI‑90 and improvements in Itch NRS. The company highlights deepening responses over time, including an increase in EASI‑100 rates: among all re‑randomized patients Q4W maintenance raises EASI‑100 from 4% at induction to 22% by week 52, with notable gains also seen on Q12W.

Safety through 52 weeks is described as favorable and consistent with prior rezpegaldesleukin data, with no new safety signals reported in the release. Nektar says the blinded maintenance findings — sustained control across EASI‑75, EASI‑90, vIGA‑AD 0/1 and Itch NRS endpoints — validate the first‑in‑class Treg mechanism and support rezpegaldesleukin as a potential best‑in‑class immune modulator. The company states these results inform its planned pivotal Phase 3 program, which will evaluate both monthly and quarterly maintenance dosing strategies.

Financing to advance pivotal program

Nektar contemporaneously launches and prices an underwritten public offering to fund development activities, including Phase 3 trials and manufacturing. The company announces an upsized sale generating roughly $400 million in gross proceeds through the issuance of common stock and pre‑funded warrants, with Jefferies, TD Cowen and Piper Sandler acting as joint bookrunners. The offering is made under an existing Form S‑3 shelf registration and is subject to customary closing conditions.

Investor briefing and next steps

Nektar schedules a conference call and webcast to discuss the REZOLVE‑AD 52‑week data and next steps, running at 8:00 a.m. ET. The company says the results support advancement into a pivotal program and will guide final dose and maintenance frequency selection for rezpegaldesleukin.