Novartis’ ligelizumab, formerly known as QGE031, has been found to be more effective than than the company’s own current therapy, Xolair (omalizumab).
In a recent study the new drug demonstrated higher effectiveness at inhibiting the major pathogenic immunoglobulin E (IgE)/FcεRI pathway in chronic spontaneous urticaria, and showed that it can bind to IgE with an 88-fold higher affinity than Xolair.
The drug is being developed as a treatment option for chronic spontaneous urticaria patients whose symptoms are inadequately controlled by H1-antihistamines, and 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.
The data reveal that ligelizumab and Xolair recognize and bind differently to IgE, with ligelizumab resulting in a significantly enhanced blockade of IgE/FcεRI signalling.
Back in October last year Novartis announced results from a Phase IIb dose-finding study, which found that more patients were completely symptom-free from chronic spontaneous urticaria with ligelizumab than Xolair.
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.
The new mechanistic research study is a “great step forward in understanding how different anti-IgE treatments can have qualitatively and functionally distinct inhibition profiles”, said one of the investigators of the study, Dr Alexander Eggel, University of Bern, Switzerland.
Chronic spontaneous urticaria is defined as persistent symptoms of urticaria for six weeks or more, and is associated with autoimmunity in approximately 45% of patients. Therapy is often difficult, however the initial approach tends to employ high-dose non-sedating antihistamines.