Novartis has pulled back the curtain on new Phase 2b data for its IgE/FceR1 pathway-blocking drug ligelizumab, showing that the therapy outperformed Roche’s Xolair (omalizumab) in key metrics as a treatment for chronic spontaneous urticaria in patients whose symptoms are inadequately controlled by H1-antihistamines.
The findings showed that, after 12 weeks of treatment, 51% and 42% of patients taking 72mg and 240mg respectively of ligelizumab achieved complete control of the hives associated with the condition, whereas the same was achieved by only 26% of those taking 300mg of Xolair.
“These study results are encouraging as we look to support patients with effective treatments to manage the debilitating symptoms of CSU,” said Dr 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 in Berlin. “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.”
Eric Hughes, the company’s Global Development Unit head for Immunology, Hepatology and Dermatology, added: “Around half of patients on current standard-of-care treatment, including omalizumab, for CSU continue to have uncontrolled symptoms. We’re encouraged by the results of this study, which is a step forward in our journey to reimagine care in immuno-dermatology to bring better treatment options for patients.”
Two Phase 3 trials are currently ongoing to investigate the efficacy of the drug, involving more than 2,000 patients in 48 countries.