Nektar Launches Phase 2b Trial for Rezpegaldesleukin in Severe Alopecia Areata

Nektar Therapeutics, a leading biotech firm specializing in the development of treatments for autoimmune disorders, has recently launched a Phase 2b clinical trial for rezpegaldesleukin (REZPEG), a groundbreaking new therapy aimed at treating severe to very severe alopecia areata. The innovative drug is an agonistic T regulatory cell biologic, which works by reducing inflammation and restoring immune balance through the expansion of functional T reg cells and the activation of various immunoregulatory pathways.

Mary Tagliaferri, the Chief Medical Officer at Nektar, has emphasized the significance of this trial for the advancement of REZPEG as a potential game-changer for alopecia areata and other autoimmune conditions. Alopecia areata is an autoimmune disease that leads to hair loss when the immune system mistakenly attacks hair follicles, which can significantly impact patients' quality of life. Existing treatments are often associated with high relapse rates and safety concerns, highlighting an urgent need for more effective and enduring solutions that address the immune system's dysfunction. Nektar is hopeful that REZPEG will offer a novel biological approach for managing alopecia, with preliminary data from the study expected in 2025.

The Phase 2b study is a global, randomized, double-blind, placebo-controlled, and dose-ranging endeavor that will assess the efficacy and safety of REZPEG in 84 participants diagnosed with severe to very severe alopecia areata. The trial will span a 36-week treatment period with two dosing regimens of REZPEG being compared to a placebo. Following the treatment, participants will be monitored for an additional 24 weeks to evaluate the treatment's durability. The study's primary goal is to measure the mean percent improvement in the Severity of Alopecia Tool (SALT) at week 36, with secondary endpoints focusing on the proportion of participants achieving a 50% or greater reduction in SALT scores at week 36 and other timepoints.

Alopecia areata affects approximately 2% of the population, with nearly 6.7 million people in the U.S. and 160 million worldwide experiencing the condition at some point in their lives. It is often linked with other autoimmune diseases and can also lead to depression and anxiety due to its significant impact on patients' well-being. Current treatments are limited, with a lack of durable options and high relapse rates, underlining the necessity for new therapies.

REZPEG is a pioneering resolution therapeutic that targets the interleukin-2 receptor complex to stimulate the growth of regulatory T cells, which are crucial in maintaining immune system balance. It is being developed for self-administration to treat a variety of autoimmune and inflammatory diseases. Alongside the alopecia areata trial, REZPEG is also being tested in a Phase 2b study for moderate-to-severe atopic dermatitis.

Nektar Therapeutics, headquartered in San Francisco with operations in Huntsville, Alabama, boasts a robust pipeline of investigational medicines in oncology and immunology, in addition to a range of approved partnered medicines. The company is at the forefront of drug development, continually striving to bring innovative treatments to market to address unmet medical needs.