Novartis takes Xolair follow-up into phase III hives trial

Novartis says it intends to move a drug for chronic spontaneous urticaria (CSU), a severe form of hives, into a phase III programme on the strength of a mid-stage study. The new drug – called ligelizumab (QGE031) – is being positioned as an improved follow-up to the Swiss company’s blockbuster Xolair (omalizumab), which has lost patent protection in the US and Europe and has biosimilar competition coming through the pipeline. Like Xolair, ligelizumab works by blocking the activity of immunoglobulin E, the main antibody culprit involved in allergic reactions such as hives, by preventing them from binding to mast cells and basophils and causing them to release histamine.
The new antibody is more effective at reducing IgE levels than Xolair, however, and Novartis hopes that will translate to improved efficacy against the intense itching and skin weals that characterize the disease and can last for weeks at a time. Xolair is approved as an add-on therapy for the treatment of CSU and is currently the only therapy recommended for use in CSU patients who do not respond to standard antihistamine therapy. It’s also approved for severe allergic asthma. In the phase II trial, ligelizumab showed a clear dose-response effect on CSU symptoms such as swelling in the skin and itchiness and outperformed Xolair on a number of measures.