Nektar Therapeutics Completes Enrollment in REZOLVE-AD Phase 2b Study for Atopic Dermatitis

Nektar Therapeutics Completes Target Enrollment in REZOLVE-AD Phase 2b Clinical Trial

Nektar Therapeutics (Nasdaq: NKTR), based in San Francisco, has recently announced the completion of its target enrollment for the REZOLVE-AD Phase 2b study, which evaluates rezpegaldesleukin in patients suffering from moderate-to-severe atopic dermatitis. This targeted enrollment involved 396 patients and took just 14 months to complete.

Rezpegaldesleukin is heralded as a first-in-class interleukin-2 receptor (IL-2R) agonist that plays a crucial role in the proliferation and activation of regulatory T cells (Tregs). Clinical trials have shown that this innovative treatment can safely and effectively increase these Tregs in a dose-dependent manner, significantly improving symptoms for individuals afflicted with various skin conditions, including atopic dermatitis.

The promising results reveal that patients experienced rapid improvements in their disease outcomes, with the benefits lasting for over 36 weeks post-treatment cessation. This exciting data was previously shared during the 2023 EADV Congress in October.

Howard W. Robin, the President and CEO of Nektar Therapeutics, expressed satisfaction with the quick enrollment process, attributing success to the enthusiasm of patients and doctors eager for novel treatment options. With less than 10% of the estimated 30 million patients with atopic dermatitis in the U.S. and Europe receiving biologics, the need for innovative therapies remains critical. Nektar Therapeutics is committed to addressing this need and anticipates releasing topline data from the study's 16-week induction period in Q2 of 2025.

The REZOLVE-AD study (NCT06136741) enrolls patients who have not been treated with biologic agents or JAK inhibitors previously. Participants were randomly assigned to receive various dosages of rezpegaldesleukin or a placebo for the initial 16-week treatment phase. Individuals demonstrating sufficient improvement, as gauged by the Eczema Area and Severity Index (EASI), will then switch to a maintenance therapy regimen with either a monthly or quarterly dosing schedule.

The primary goal of this trial is to evaluate the mean improvement in EASI scores at the conclusion of the 16-week treatment period. Secondary objectives will assess the percentage of patients achieving a Validated Investigator Global Assessment (vIGA-AD) score of 0 or 1, those attaining EASI-75, and those who achieve a four-point improvement on the Itch Numeric Rating Scale (NRS).

Initiated in October 2023, this crucial trial is being conducted across approximately 110 global sites, predominantly in Europe where 67% of the patients were enrolled, followed by the United States (17%), Canada (11%), and Australia (5%). The screening criteria ensures that only those with a minimum EASI score of 16.0, a Body Surface Area of 10%, and a vIGA-AD score of at least 3 are included in the study.

Understanding Rezpegaldesleukin

Rezpegaldesleukin targets the underlying immune dynamics responsible for autoimmune and inflammatory diseases. By activating regulatory T cells through IL-2 receptor stimulation, it seeks to restore balance within the immune system. As a self-administered injection, rezpegaldesleukin is being explored not only for atopic dermatitis but also in other conditions like alopecia areata, under a separate study called REZOLVE-AA.

Atopic dermatitis itself is the leading form of eczema, impacting approximately 30 million individuals in the U.S. Symptoms arise when a compromised skin barrier permits allergens and irritants to provoke immune responses leading to inflammation.

Nektar Therapeutics remains a pioneering force in the biotechnology sector, focusing on remedies that tackle the root causes of chronic and autoimmune diseases. In addition to rezpegaldesleukin, Nektar's pipeline includes various treatments targeting different illnesses, highlighting the company’s dedication to advancing healthcare solutions for complex conditions.

With Nektar's ongoing development and commitment to innovation, both patients and the medical community eagerly await the outcomes from the REZOLVE-AD study, potentially paving the way for more effective therapies for those suffering from moderate-to-severe atopic dermatitis.