Novartis' Ligelizumab Yields Mixed Results In Chronic Spontaneous Urticaria Trials

Novartis AG (NVS) on Monday announced mixed topline results from its twin phase III trials evaluating Ligelizumab in chronic spontaneous urticaria, dubbed PEARL 1 and PEARL 2.

Chronic spontaneous urticaria, or CSU, is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks, and affects up to 1 percent of the population at any one time.

The purpose of the PEARL 1 and PEARL 2 trials is to establish efficacy and safety of Ligelizumab in chronic spontaneous urticaria by demonstrating better efficacy over approved CSU drug *Xolair and over placebo. *Xolair is jointly developed by Novartis and Genentech.

Ligelizumab demonstrated superiority compared with placebo at Week 12 in the PEARL 1 and PEARL 2 trials, but failed to demonstrate superiority over Xolair.

The PEARL 1 and PEARL 2 trials are expected to be completed in the second half of 2022.

Commenting on the trial results, John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis, said, "We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU. We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need."

NVS closed Friday's trading at $85.90, down 0.20 percent.

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