Nektar Therapeutics Inc NKTR stock is surging on Tuesday, with a session volume of 4.7 million compared to an average volume 239.7K as per data from Benzinga Pro.
The company released statistically significant data from the 16-week induction period of the ongoing Phase 2b REZOLVE-AD study of investigational rezpegaldesleukin.
The global Phase 2b study is being conducted in 393 patients with moderate-to-severe atopic dermatitis. Patients in the study received three under-the-skin shots of rezpegaldesleukin.
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The trial met its primary endpoint of the mean improvement in Eczema Area and Severity Score (EASI) from baseline at week 16 for all three dose arms of rezpegaldesleukin versus placebo.
All three dose arms also achieved statistical significance at week 16 for the key secondary endpoints of EASI-75 (percent of patients who achieve ≥75% reduction in EASI from baseline), EASI-50 (percent of patients who achieve ≥50% reduction in EASI from baseline) and BSA (mean percent improvement in Body Surface Area score from baseline).
After 16 weeks, patients had a 53% to 61% improvement in symptoms. This was compared to a 31% improvement for the placebo group.
The q2w arms of rezpegaldesleukin (high and middle doses) achieved statistical significance at week 16 for the key secondary endpoints of vIGA-AD 0/1 (percent of patients achieving a score of 0 or 1 on the validated Investigator’s Global Assessment for Atopic Dermatitis with ≥ 2-point reduction from baseline) and Itch NRS (percent of patients with baseline ≥ 4 who experienced a ≥ 4-point reduction in the Itch Numerical Rating Score from baseline).
In addition, at week 16, the high dose of 24 µg/kg q2w achieved statistical significance on EASI-90 (percent of patients who achieve ≥ 90% reduction in EASI from baseline).
Across all three dose arms, translational blood biomarker data demonstrate robust on-target and dose-dependent pharmacological activity.
The safety profile for the 16-week induction period for rezpegaldesleukin was consistent with previously reported results.
In the pooled rezpegaldesleukin arms, TEAEs, excluding ISRs, were reported in 60.3% of patients and in 57.5% of placebo-treated patients.
There was no increased risk of conjunctivitis, oral ulcers, or infections, including oral herpes, in the rezpegaldesleukin arms.
Nektar plans to submit these REZOLVE-AD 16-week induction results for presentation at a medical conference later in 2025.
Price Action: NKTR stock is trading higher by 108.6% to $19.90 premarket at last check Tuesday.
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