Nektar Therapeutics (NASDAQ:NKTR) saw its shares tick up 3% Tuesday morning after the company released maintenance-phase data from REZOLVE-AD, its global Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis.
The clinical-stage biotech reported that patients who continued on rezpegaldesleukin after an induction period maintained strong efficacy outcomes at week 52 with both monthly and quarterly dosing schedules. According to the company, 71% of patients on 24 µg/kg monthly dosing and 83% on 24 µg/kg quarterly dosing preserved EASI-75 responses at week 52. On the vIGA-AD 0/1 measure, 85% of monthly-dosed patients and 63% of quarterly-dosed patients maintained response through week 52.
In addition to those maintained response rates, Nektar reported increases in EASI-100 rates, describing up to a 5-fold rise in complete lesion clearance relative to earlier points in the study.
The REZOLVE-AD trial enrolled 393 patients with moderate-to-severe atopic dermatitis. After a 16-week induction phase, participants who achieved at least a 50% improvement in EASI scores were re-randomized to continue rezpegaldesleukin either monthly or quarterly for an additional 36 weeks, yielding the 52-week maintenance dataset now reported.
On safety, the company said the maintenance profile of rezpegaldesleukin was consistent with prior results and that no new safety concerns emerged during the maintenance period. Across aggregated patients, the discontinuation rate due to adverse events was 3.5%.
“These data validate the novel first-in-class regulatory T-cell mechanism as a potential best-in-class immune-modulator,” the company said, adding that the durability of maintained response rates supports advancement to a pivotal Phase 3 program evaluating both monthly and quarterly maintenance dosing.
Nektar also indicated its aim to file a Biologics License Application for rezpegaldesleukin in 2029. The company’s statement tied the maintenance durability observed in REZOLVE-AD to plans for a pivotal study that would evaluate the same maintenance regimens.
Market reaction to the release was modest, with NKTR shares rising about 3% on the session when the data were disclosed. Investors and market participants will likely focus on the design and eventual outcomes of the planned pivotal Phase 3 program and the pathway toward the 2029 BLA target as next milestones.
Summary
Nektar reported durable responses for rezpegaldesleukin in the maintenance portion of its Phase 2b REZOLVE-AD trial. High rates of maintained EASI-75 and vIGA-AD 0/1 responses were observed at week 52 with both monthly and quarterly 24 µg/kg dosing. Safety remained consistent with prior reports and discontinuations due to adverse events totaled 3.5% across aggregated patients. The company said the results support moving to a pivotal Phase 3 program and plans a BLA submission in 2029.