Novartis' ligelizumab flops in chronic spontaneous urticaria trial

Swiss pharma giant Novartis (NOVN: VX) has announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU).

The studies met their primary endpoints of superiority for the high-affinity anti-IgE antibody, ligelizumab, versus placebo at week 12, but not versus omalizumab, the standard of care treatment from Roche (ROG: SIX) and Novartis.

CSU is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives on the skin, angioedema or both for at least six weeks and affects up to 1% of the population at any one time. Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines.