Nektar discloses fresh information from the Phase 2b REZOLVE-AD trial, assessing Rezpegaldesleukin, presented in late-breaker oral discussion during EADV 2025 conference
Nektar Therapeutics, a clinical-stage biotechnology company specialising in the development of treatments for autoimmune and chronic inflammatory diseases, has announced new data from its REZOLVE-AD Phase 2b study of rezpegaldesleukin. The data, presented by Dr. Jonathan Silverberg at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France, show promising results for patients with moderate-to-severe atopic dermatitis.
The REZOLVE-AD study randomized 393 patients to receive subcutaneous treatment with three doses of rezpegaldesleukin or placebo. The developer of rezpegaldesleukin, an IL-2 pathway activator and Treg proliferator, is Nektar Therapeutics. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases, and it targets the interleukin-2 receptor complex in the body to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells.
Approximately 68% of the enrolled and treated patients were in Europe, with countries such as Poland, Bulgaria, Germany, Czech Republic, Spain, Croatia, and Hungary participating. The United States and Canada each accounted for about 16% and 11% of the enrolled and treated patients, respectively, while 5% were enrolled and treated in Australia.
Key enrollment criteria in the study included a minimum EASI score of 16.0, a minimum Body Surface Area (BSA) of 10% and a minimum vIGA-AD of 3. The REZOLVE-AD trial (NCT06136741) was initiated in October 2023 and enrolled patients across approximately 110 sites globally. Patient randomization was stratified based on baseline disease severity measured by vIGA-AD and geographic region.
Rezpegaldesleukin achieved statistical significance on the primary endpoint of mean improvement in Eczema Area and Severity Index (EASI) at week 16 over baseline for all rezpegaldesleukin arms versus placebo. EASI-75 responses at crossover week 16 and 24 were 50% and 62%, respectively, and percent of patients with a vIGA-AD 0/1 response at crossover week 16 and 24 were 28% and 38%, respectively.
Results presented included interim data for 42 placebo patients who crossed over into the treatment escape arm and received 24 weeks of treatment with high dose rezpegaldesleukin (24 μg/kg q2w). High dose rezpegaldesleukin showed a mean improvement in EASI score from baseline of 61% at week 16. Continuous treatment with rezpegaldesleukin demonstrated deepening of responses, with mean percent reduction in EASI at crossover week 16 and 24 being 68% and 75%, respectively.
Statistical significance at week 16 was also achieved for key secondary endpoints measuring disease reduction in patients with moderate-to-severe atopic dermatitis. These findings suggest that rezpegaldesleukin may be a potential first-in-class resolution therapeutic that may address the underlying immune system imbalance in people with many autoimmune and inflammatory conditions.
Rezpegaldesleukin is wholly owned by Nektar Therapeutics. The company is committed to continuing the development of rezpegaldesleukin for the treatment of atopic dermatitis and other autoimmune and inflammatory diseases.
