FDA grants rezpegaldesleukin fast track to treat moderate, severe atopic dermatitis
The investigational biologic targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells.
FDA grants rezpegaldesleukin fast track to treat moderate, severe atopic dermatitis | Image Credit: © Марина Терехова - © Марина Терехова - stock.adobe.com.
Rezpegaldesleukin (Rezpeg; Nektar Therapeutics) has been granted fast track designation by the FDA for the treatment of adult and pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescriptions, or if such therapies are not advisable.1
The announcement on February 10, 2025, from the manufacturer Nektar Therapeutics, noted that in the indicated patient profile, rezpegaldesleukin has been shown to rapidly improve measurable exploratory disease outcomes during a 12-week induction treatment phase and for at least 36 weeks after ceasing treatment.
The company previously announced proof-of-concept efficacy and safety data in a phase 1b study of rezpegaldesleukin in AD patients at the 2023 EADV Congress.
According to results, high dose rezpegaldesleukin demonstrated significant improvement over placebo in Eczema Area and Severity Index (EASI) LS mean percent change compared to placebo (P = 0.002) and body surface area mean percent change compared to placebo (P = 0.0158).2
The phase 2b REZOLVE-AD (NCT06136741) study is active, having enrolled 398 patients with moderate-to-severe AD who had not previously received treatment with biologic or JAK inhibitor therapies. According to Jonathan Zalevsky, PhD, senior vice president and chief research & development officer at Nektar, topline data is from this trial is expected later in 2025.1
"We are pleased that rezpegaldesleukin has been designated a Fast Track product," said Zalevsky in a press release. "Rezpegaldesleukin has the potential to address a significant unmet need for the millions of patients living with moderate-to-severe atopic dermatitis. We remain on track to announce topline data from the induction period of our phase 2b REZOLVE-AD study in the second quarter of this year. This designation will now allow us to collaborate closely with the agency on the design of the registrational program for rezpegaldesleukin once we've completed phase 2."
In REZOLVE-AD, patients were randomized across 3 different dose regiments and placebo for a 16-week induction treatment period. After, patients who meet an EASI score threshold for advancement to maintenance are re-randomized to 1 of 2 maintenance regimens at original dose level to receive maintenance therapy either once per month or once every 3 months.
According to Nektar, the primary endpoint of the study is mean improvement of EASI score at the end of the 16-week induction period. Secondary outcomes include:
- Patients achieving Validated Investigator Global Assessment (vIGA-AD) of 0 or 1
- Patients achieving EASI-75
- Patients achieving a greater than or equal to a 4-point improvement in Itch Numeric Rating Scale (NRS)
The trial is randomized, double-blind, parallel-group, and placebo-controlled.3
In addition to the REZOLVE-AD study, rezpegaldesleukin is also being evaluated in the REZOLVE-AA phase 2b study for the treatment of severe-to-very severe alopecia areata in adults.4
References:
1. Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate-to-severe atopic dermatitis. Nektar Therapeutics. Press release. February 10, 2025. Accessed February 10, 2025. https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-receives-fast-track-designation
2. Silverberg J. Efficacy and Safety of Single Agent Rezpegaldesleukin, A Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, in the Treatment of Atopic Dermatitis: Final Results from a Randomized Phase 1b Study. Session. Presented at: 2023 EADV Congress. October 2023.
3. A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD). ClinicalTrials.gov. Updated January 28, 2025. Accessed February 10, 2025. https://clinicaltrials.gov/study/NCT06136741?intr=REZOLVE-AD&rank=1
4. A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA). ClinicalTrials.gov. Updated January 10, 2025. Accessed February 10, 2025. https://clinicaltrials.gov/study/NCT06340360?intr=REZOLVE-AA&rank=1
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