SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR) announced Tuesday that its experimental atopic dermatitis treatment rezpegaldesleukin showed sustained efficacy in the 36-week maintenance period of its Phase 2b REZOLVE-AD study. The biotech company, currently valued at approximately $754 million, has seen its shares surge over 250% in the past year according to InvestingPro data.
The trial evaluated patients with moderate-to-severe atopic dermatitis who received either monthly or quarterly maintenance dosing after achieving at least 50% improvement during the initial 16-week treatment period.
According to the company, 71% and 83% of patients maintained EASI-75 responses (75% improvement in disease severity) with monthly and quarterly dosing of the 24 µg/kg dose, respectively. Additionally, 85% and 63% maintained validated Investigator Global Assessment scores of 0/1 (clear or almost clear skin) with the same dosing regimens.
The data showed increasing efficacy over time, with a 2 to 5-fold increase in patients achieving complete disease clearance (EASI-100) from week 16 to week 52.
"These data show that rezpegaldesleukin, as a broad-based Treg agonist, is emerging as one of the most important mechanisms in development to treat atopic dermatitis," said Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences, in the press release.
The safety profile remained consistent with earlier results, with injection site reactions being the most common adverse event. The discontinuation rate due to adverse events was 3.5% across all patients.
Rezpegaldesleukin works by stimulating regulatory T-cells to help restore immune system balance. The FDA previously granted Fast Track designation for the drug in atopic dermatitis and alopecia areata.
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