(Investorideas.com Newswire), a platform for big investment ideas including AI and biotech stocks, issues a news and trading alert for Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on developing novel immunological therapies.
The stock is among the Nasdaq’s top percentage gainers on the news and is currently trading at $53.05, up 15.98, with a gain of 43.11%, with a daily high of $55.43.
Nektar Therapeutics today announced positive results from the 36-week blinded maintenance period of the 52-week REZOLVE-AD study of rezpegaldesleukin, a novel regulatory T cell (Treg) biologic, in patients with moderate to severe atopic dermatitis (AD).
The global REZOLVE-AD Phase 2b trial enrolled 393 patients with moderate to severe atopic dermatitis. Patients were randomized (3:3:3:2) to receive subcutaneous treatment with three doses of rezpegaldesleukin or placebo for a 16-week induction period. After a 16-week induction period, rezpegaldesleukin-treated patients who achieved an Eczema Area Severity Index (EASI) score reduction of at least 50 were re-randomized (1:1) to continue with the same induction dose given monthly (Q4W) or quarterly (Q12W) through week 52 in a 36-week blinded maintenance period. Patients who did not achieve an EASI-50 during the 16-week induction period were enrolled in a treatment arm for up to 36 weeks.
Rezpegaldesleukin demonstrated long-term durability and persistent AD disease symptom improvement in maintenance
Durability of treatment effect: Q4W and Q12W dosing regimens resulted in sustained disease control for EASI-75, EASI-90, validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) response and Itch Numerical Rating Scale (NRS) response, with the 24 µg/kg Q4W and Q12W regimens demonstrating the highest maintenance of response over week 52.
New and deepening responses over time: A significant proportion of patients achieved new EASI-75, EASI-90, Itch-NRS, and vIGA-AD 0/1 responses at week 52, supporting better disease control with long-term therapy and less frequent dosing.
Meaningful conversions to EASI-100: During maintenance treatment, a two- to five-fold increase in the percentage of patients achieving EASI-100 was observed at the 24 mcg/kg Q4W and Q12W dosing regimens. Among all rerandomized patients from week 16 to week 52, Q4W maintenance dosing increased EASI-100 response from 4% to 22% and Q12W dosing increased EASI-100 response from 9% to 18%. Among rerandomized patients who had an EASI-75 or vIGA-AD response at maintenance baseline, Q4W dosing increased the EASI-100 response from 6% to 30% and Q12W dosing increased the EASI-100 response from 14% to 27%.
“These data demonstrate that rezpegaldesleukin, as a broad-based Treg agonist, is emerging as one of the key mechanisms in development for the treatment of atopic dermatitis,” said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at the George Washington University School of Medicine and Health Sciences in Washington, DC. “With both monthly and quarterly maintenance dosing, new and sustained responses were observed on key endpoints of EASI-75, vIGA-0/1 and pruritus, with a high proportion of patients achieving complete clearance on EASI-100.”
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https://ca.finance.yahoo.com/news/rezolve-ad-maintenance-data-atopic-120000860.html
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