Nektar Therapeutics Gets Fast Track for Rezpegaldesleukin in Treating Moderate-to-Severe Atopic Dermatitis

Nektar Therapeutics, a biotechnology company based in San Francisco, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, rezpegaldesleukin, for treating atopic dermatitis in both adults and pediatric patients aged 12 and above. This designation is aimed at expediting the development and review process of drugs that treat serious conditions and fulfill unmet medical needs.

Rezpegaldesleukin is a biologic therapy that targets the interleukin-2 receptor complex, which plays a pivotal role in stimulating regulatory T cells (Tregs), crucial for inhibiting immune responses. This approach is intended to revitalize the immune balance in patients suffering from autoimmune and inflammatory diseases.

In clinical evaluations, rezpegaldesleukin demonstrated promising outcomes during a 12-week induction phase, as well as sustained efficacy for at least 36 weeks post-treatment in patients with moderate-to-severe atopic dermatitis. The proof-of-concept data was earlier shared at the 2023 EADV Congress.

Dr. Jonathan Zalevsky, Senior Vice President and Chief Research & Development Officer at Nektar, expressed optimism about the Fast Track designation, highlighting the significant unmet needs among patients with moderate-to-severe atopic dermatitis that rezpegaldesleukin aims to address. He further mentioned that Nektar plans to release topline data from the Phase 2b REZOLVE-AD study in the second quarter of the year. This designation by the FDA is anticipated to facilitate closer collaboration with the agency for the design of their registrational program post the completion of Phase 2 studies.

The Fast Track process by the FDA is structured to accelerate the development of treatments for grave conditions. It allows more frequent interactions and consultations regarding the drug's developmental framework and potential eligibility for expedited review processes.

The REZOLVE-AD study is a crucial part of rezpegaldesleukin’s development, enrolling 398 patients with moderate-to-severe atopic dermatitis who had not undergone treatment with biologic or JAK inhibitor therapies. The participants are randomized into various dose regimens of rezpegaldesleukin and a placebo over a 16-week induction. Success in the induction phase could lead to maintenance therapy, either monthly or quarterly, for patients meeting certain criteria. The study evaluates the mean improvement in Eczema Area and Severity Index (EASI) scores as its primary endpoint, with secondary endpoints focusing on other metrics of disease improvement.

Rezpegaldesleukin is also under investigation in other studies, including the REZOLVE-AA trial, which focuses on treating severe alopecia areata. This underscores the potential versatility of rezpegaldesleukin in addressing multiple autoimmune and inflammatory conditions.

Atopic dermatitis, a prevalent form of eczema, affects around 30 million individuals in the United States alone, characterized by skin barrier defects leading to inflammation. Nektar Therapeutics is committed to addressing such conditions by developing treatments like rezpegaldesleukin, which leverages the modulation of regulatory T cells to potentially restore immune system equilibrium.

Nektar is also working on other innovative therapies, with a pipeline that includes a bivalent tumor necrosis factor receptor type II antibody and bispecific programs, alongside a modified hematopoietic colony-stimulating factor protein. Additionally, the company collaborates on evaluating NKTR-255, an investigational agent aiming to enhance the body’s natural cancer-fighting capabilities.