Phase 2b study of rezpegaldesleukin for atopic dermatitis reaches target enrollment

Key takeaways:

• Rezpegaldesleukin is a first-in-class interleukin-2 receptor agonist that proliferates and activates regulatory T cells.
• The study reached its target enrollment of 396 patients.

Nektar Therapeutics has completed target enrollment for its phase 2b study of rezpegaldesleukin for the treatment of patients with moderate to severe atopic dermatitis, the company announced in a press release.

“There are approximately 30 million people living with atopic dermatitis in the U.S. and Europe. Less than 10% of these patients who can receive biologics in the U.S. and Europe currently do, and the only available therapies for them are interleukin-13-based treatments and Janus kinase inhibitors,” Mary Tagliaferri, MD, senior vice president and chief marketing officer of Nektar Therapeutics, told Healio. “These agents don’t work for all patients and their adverse events limit usage for many. We believe a novel T regulatory cell mechanism is key to helping more patients with this chronic skin disorder.”

REZOLVE-AD, the phase 2b study, is set to investigate the efficacy and safety of rezpegaldesleukin, a first-in-class interleukin-2 receptor agonist that proliferates and activates regulatory T cells for the treatment of moderate to severe AD in patients that had not previously received biologic or Janus kinase inhibitor therapy.

According to the release, the study reached its target enrollment of 396 patients within a short amount of time due to the success of rezpegaldesleukin in a previous trial.

“We had strong interest in this study because of the early data and because of the unique new mechanism of action for rezpegaldesleukin,” Tagliaferri explained. “While atopic dermatitis is a competitive and challenging indication to recruit ... we managed to complete enrollment of the study in just 14 months.”

According to the release, each patient will be randomly assigned to receive one of three different dose regimens of rezpegaldesleukin or placebo over a 16-week induction period. After this, patients meeting a certain EASI threshold will advance to a maintenance therapy regimen of once a month or once every 3 months.

“Rezpegaldesleukin has the potential to be highly disruptive in the biologic treatment landscape for AD as demonstrated by the deep and durable responses we observed in our phase 1b study,” Tagliaferri told Healio. “We’re looking forward to the results from this phase 2b study, which we expect in the second quarter of this year, to further support these findings.”