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Nektar Therapeutics Announces Start Of Phase 3 Zenith AD Program Evaluating Rezpegaldesleukin In Moderate-To-Severe Atopic Dermatitis

Nektar Therapeutics announced the initiation of the first two global registrational trials (ZENITH AD-1 and ZENITH AD-2) in the Phase 3 ZENITH AD program for rezpegaldesleukin. The ZENITH AD program is evaluating rezpegaldesleukin in patients who are 12 years of age or older with moderate-to-severe atopic dermatitis. The program includes three global, randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment-naive patients and ZENITH AD-3 will enroll patients with prior systemic biologic and/or JAK inhibitor treatment experience. Rezpegaldesleukin is a first-in-class regulatory T-cell (T-reg) biologic designed to address imbalances in the immune system that underlie many autoimmune disorders and chronic inflammatory conditions. It targets the IL-2 receptor complex to preferentially stimulate the proliferation of T-regs to restore immune balance. The Phase 3 program is based upon clinically meaningful efficacy and favorable safety data observed in a 393-patient Phase 2b study with monthly and quarterly maintenance dosing, including an up to five-fold increase in EASI-100 between 16 and 52 weeks. The ZENITH AD program includes these first two 510-patient studies in patients who are systemic biologic/JAK inhibitor treatment-naive (ZENITH AD-1 and ZENITH AD-2) and one 510-patient study in patients who are treatment-experienced (ZENITH AD-3), which will begin in September. Initial Phase 3 topline data is expected in mid-2028 with BLA submission targeted for 2029. The ZENITH AD global registrational program is targeting enrollment of a total of 1,530 patients with moderate-to-severe atopic dermatitis who are age 12 and older across North America, Europe and Asia-Pacific. Each of the three pivotal studies includes a 24-week blinded induction period in which patients are randomized 2:1 to receive rezpegaldesleukin 24 micrograms per kilogram or placebo administered subcutaneously every two weeks. Patients who achieve an EASI-75 (Eczema Area and Severity Index 75) and/or IGA 0/1 (Investigator's Global Assessment of Atopic Dermatitis of 0 or 1) response at Week 24 advance to a 28-week blinded maintenance period and are re-randomized 2:2:1 to monthly dosing, quarterly dosing, or placebo, with patients not meeting the threshold entering an open-label treatment escape arm. The primary endpoint of the ZENITH AD studies is IGA 0/1 response at Week 24 with EASI-75 response at Week 24 as a key secondary endpoint. For registration in jurisdictions outside the U.S., the co-primary endpoints are IGA 0/1 response and EASI-75 response at Week 24. Other key secondary endpoints include: EASI-90 and Itch Numeric Rating Scale (NRS), with a 4-point or greater reduction from baseline. There are also several patient-reported outcomes as secondary endpoints. Given that approximately 25% of patients with moderate-to-severe atopic dermatitis have comorbid asthma, the program includes a prespecified assessment of asthma control through the ACQ-5 (Asthma Control Questionnaire-5) in patients with a history of asthma at baseline. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases, including atopic dermatitis, alopecia areata and Type 1 diabetes. In February 2025, the U.S. FDA granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In July 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg.

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