Nektar’s Rezpegaldesleukin Delivers Sustained Improvement for Atopic Dermatitis—Phase 2b Results Highlight Deepening Patient Response Over Time
Efficacy Endpoints Show Robust Improvements at 16 Weeks, Widening After 24 Weeks
Nektar Therapeutics released new results from its ongoing REZOLVE-AD Phase 2b study of rezpegaldesleukin at the European Academy of Dermatology and Venereology Congress in Paris. This interleukin-2 pathway agonist is drawing attention for achieving primary and secondary efficacy endpoints in patients with moderate-to-severe atopic dermatitis. Notably, extended treatment demonstrated a continued deepening of clinical benefit well past the initial 16-week induction period.
Table 1. Week 16 Efficacy—Statistically Significant Gains Across Doses
| Endpoint | 24 g/kg q2w (High Dose) |
18 g/kg q2w (Middle Dose) |
24 g/kg q4w (Low Dose) |
Placebo |
|---|---|---|---|---|
| Mean Improvement in EASI Score | 61% | 58% | 53% | 31% |
| EASI-75 | 42% | 46% | 34% | 17% |
| vIGA-AD 0/1 | 20% | 26% | 19% | 8% |
| EASI-90 | 25% | 18% | 17% | 9% |
| Itch NRS (=4-point reduction) | 42% | 35% | 23% | 16% |
| Mean Improvement in BSA | 54% | 48% | 43% | 17% |
| EASI-50 | 66% | 66% | 55% | 34% |
At week 16, the high dose (24 g/kg q2w) and middle dose both showed greater than 60% mean improvement from baseline in the Eczema Area and Severity Index (EASI) versus 31% for placebo. Key secondary endpoints—including EASI-75 and the Itch Numerical Rating Scale—showed similarly robust responses compared to placebo, with a rapid onset observed early in the treatment course.
Patient-Reported Outcomes Point to Improved Quality of Life
Beyond physician-assessed metrics, patient-reported measures revealed substantial benefit in those receiving rezpegaldesleukin. Notable findings include higher percentages of patients achieving clinically meaningful improvement in life quality and control of their disease.
Table 2. Week 16 Patient-Reported Outcomes
| Endpoint | 24 g/kg q2w | 18 g/kg q2w | 24 g/kg q4w | Placebo |
|---|---|---|---|---|
| DLQI (>4-point reduction) | 72% | 64% | 73% | 54% |
| ADCT (>5-point reduction) | 67% | 61% | 61% | 35% |
| Pain NRS (>4-point reduction) | 45% | 35% | 23% | 22% |
| ADSS Q1 (>1.25-point reduction) | 57% | 41% | 46% | 30% |
Among those on the high dose, 72% reported at least a 4-point improvement on the Daily Life Quality Index (DLQI), while two-thirds showed significant disease control as measured by the Atopic Dermatitis Control Tool (ADCT), both substantially outpacing placebo.
Clinical Response Deepens With Prolonged High-Dose Treatment
The study design enabled patients on placebo who did not achieve adequate response by week 16 to crossover into a high-dose treatment arm. Interim data for this group demonstrated that benefits of rezpegaldesleukin further increase with continued therapy: mean EASI score reduction rose from 68% at 16 weeks to 75% at 24 weeks, while the proportion achieving EASI-75 improved from 50% to 62%. Likewise, 38% reached near-complete or complete clearance on vIGA-AD 0/1, compared to 28% at 16 weeks.
Safety Profile Remains Acceptable Through 16 Weeks
The incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations remained comparable to placebo. Most events were manageable and resolved during the study.
Table 3. Safety Outcomes Over 16 Weeks
| 24 g/kg q2w | 18 g/kg q2w | 24 g/kg q4w | Pooled Drug Arms | Placebo | |
|---|---|---|---|---|---|
| Patients with any TEAE* | 66.3% | 56.6% | 58.2% | 60.3% | 57.5% |
| Any Serious AE | 1.0% | 3.8% | 0% | 1.6% | 0% |
| Any Drug-Related Serious AE | 0% | 1.9% | 0% | 0.6% | 0% |
| Any Severe AE | 2.9% | 5.7% | 0.9% | 3.1% | 1.4% |
| Drug-Related Severe AE | 2.9% | 2.8% | 0% | 1.9% | 0% |
| TEAEs leading to drug discontinuation | 7.7% | 4.7% | 4.5% | 5.6% | 0% |
*Excludes injection site reactions. All severe/serious AEs resolved during the study.
Regulatory Milestones and Next Steps
Rezpegaldesleukin’s potential is further underscored by Fast Track designation from the U.S. FDA for both atopic dermatitis and alopecia areata. Later this year, pivotal data for alopecia areata are anticipated, setting up the next chapter for Nektar’s immunology pipeline.
Key Takeaway: Data Signal Long-Lasting Benefit and Advancing Mechanism
The data from REZOLVE-AD highlight that rezpegaldesleukin can offer meaningful, sustained improvements in atopic dermatitis—both in physician-measured and patient-experienced terms—with effects deepening beyond initial induction. While these results do not guarantee future regulatory success, the magnitude and consistency of responses may be compelling for those watching new treatments in immune-mediated skin disease. Nektar’s late-stage pipeline, led by this candidate, is poised to drive attention as further data emerge through the year.
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