Novartis has announced results from a Phase IIb dose-finding study, which found that more patients were completely symptom-free from chronic spontaneous urticaria with ligelizumab (QGE031) than Xolair (omalizumab) 300 mg.
The data, published in The New England Journal of Medicine, showed an average complete response rate of 42% for 240 mg and 72 mg of ligelizumab at Week 12, compared with 26% for those taking 300 mg of Xolair.
The drug also achieved complete control of hives in 51% and 42% of patients treated, compared with 26% of patients treated with Xolair.
Ligelizumab, a monoclonal antibody blocking the IgE/FceR1 pathway, is being developed as a treatment option for chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines
The treatment is currently being investigated in an ongoing Phase III clinical trial program which includes Phase III trials PEARL 1 and PEARL 2, globally recruiting more than 2,000 patients across 48 countries around the world.
“These study results are encouraging as we look to support patients with effective treatments to manage the debilitating symptoms of CSU,” said Marcus Maurer, professor of dermatology and allergy and director of research at the Department of Dermatology and Allergy, Allergie-Centrum-Charité of the Charité–Universitätsmedizin.
He continued, “CSU is a severe skin disease that significantly impacts the lives of patients, who may experience unpredictable and persistent itchy hives, sometimes with painful swelling of the skin."
Hives (urticaria) are red, itchy welts that result from a skin reaction. The welts vary in size and appear and fade repeatedly as the reaction runs its course. The condition is considered chronic hives if the welts appear for more than six weeks and recur frequently over months or years.