Nektar’s shares have surged more than twofold after a Phase IIb study of its atopic dermatitis (AD) therapy rezpegaldesleukin (rezpeg) successfully met its primary and key secondary endpoints.
The US-based biotech reported a statistically significant change in Eczema Area and Severity Index (EASI) score compared with placebo after 16 weeks of treatment in all three treatment arms.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
In the study (NCT06136741), there was also a statistically significant improvement in the EASI 75 score and Body Surface Area (BSA) in all three doses. In the high and middle doses, investigators reported a significant improvement in the Itch Numerical Rating Scale (NRS) and Validated Investigator’s Global Assessment for AD (vIGA-AD). The high-dose group also saw a statistically significant change on the EASI 90 scale.
Investors were elated with the data, sending Nektar’s stock price soaring by 109% on the announcement, from a market close of $9.54 on 23 June to an open of $20.00 on 24 June.
The therapy was previously being developed in partnership with pharma giant Eli Lilly. However, the companies later cut ties, with Nektar accusing Lilly of publishing “erroneous data” on the therapy from Phase Ib studies. A month after accusing Lilly of the error, Nektar published new data, which it stated showed statistically meaningful change in all three clinical efficacy endpoints in an AD study.
Rezpegaldesleukin, an IL-pathway agonist and regulatory T-cell (Treg) proliferator, was being investigated in the REZOLVE-AD study, which enrolled 393 patients with moderate-to-severe AD, also known as eczema. Patients were randomised into four arms, comprising placebo, or high, medium or low doses.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe safety profile of rezpeg in the Phase IIb study was consistent with previously reported results. Notably, there was no increased risk of incidence of conjunctivitis, oral herpes, or oral ulcers with this mechanism of action, as is seen with other therapies.
Professor Jonathan Silverberg at George Washington University School of Medicine and Health Sciences said: “These data from REZOLVE-AD show a fast onset of both EASI response and itch relief within the first few doses of rezpeg treatment, which are important metrics for physicians as they assess treatment options in AD. This shows the advantage of a broad-based Treg mechanism over other immune-modulation approaches in development to treat the disease.”
In recent years, Sanofi and Regeneron’s Dupixent (dupilumab) has been one of the leading AD therapies, especially in patients who have not responded to corticosteroid therapy. Dupixent is also approved in several other indications, including asthma, chronic obstructive pulmonary disorder (COPD), and hives.
Nektar is also looking for a multi-indication approval, with Phase II trials also ongoing in systemic lupus erythematosus (SLE), ulcerative colitis (UC) and alopecia areata.
According to GlobalData analysis, Dupixent made $14.14bn in sales in 2024, with a 2030 sales estimate of $25.9bn. If approved, GlobalData predicts rezpeg will make $295m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
