Nektar starts Phase 3 trials for Rezpegaldesleukin
Nektar Therapeutics launched the ZENITH AD-1 and ZENITH AD-2 trials, the first two global Phase 3 studies for Rezpegaldesleukin, targeting a BLA submission in 2029. The program follows positive Phase 2b data showing significant EASI-100 improvements. A third trial for treatment-experienced patients starts in September.

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Nektar Therapeutics has initiated the first two global registrational trials, ZENITH AD-1 and ZENITH AD-2, in its Phase 3 program for Rezpegaldesleukin. The company expects initial topline data from these studies in mid-2028, with a Biologics License Application (BLA) submission targeted for 2029. The development aims to address treatment needs for patients with atopic dermatitis.
The Phase 3 program is based on clinically meaningful efficacy and favorable safety data observed in a 393-patient Phase 2b study. This earlier study utilized monthly and quarterly maintenance dosing regimens. Notably, the data showed an up to five-fold increase in EASI-100 scores between week 16 and week 52.
The ZENITH AD program comprises three studies. The first two, ZENITH AD-1 and ZENITH AD-2, are 510-patient studies focused on patients who are systemic biologic or JAK inhibitor treatment-naive. A third study, ZENITH AD-3, will enroll 510 patients who are treatment-experienced and is scheduled to begin in September.
| Study Name | Patient Count | Patient Population |
|---|---|---|
| ZENITH AD-1 | 510 | Systemic biologic/JAK inhibitor treatment-naive |
| ZENITH AD-2 | 510 | Systemic biologic/JAK inhibitor treatment-naive |
| ZENITH AD-3 | 510 | Treatment-experienced |
How will Rezpegaldesleukin differentiate itself from existing atopic dermatitis treatments upon its potential 2029 launch?
What impact will the long development timeline have on Nektar's financial resources and partnership strategies?
Could the favorable safety profile observed in Phase 2b position Rezpegaldesleukin as a preferred first-line biologic option?

























