By Alex Keown


Novartis is taking a treatment for persistent hives into Phase III trials after a mid-stage trial showed that the medication, ligelizumab (QGE031), outperformed Xolair in patients with chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines.

Novartis, based in Basel, Switzerland, said this morning that it will conduct two Phase III studies, PEARL 1 and PEARL 2 that will include more than 2,000 patients. CSU is a severe skin condition that includes a long-term hives affliction. Patients afflicted with CSU see a major impact on quality of life due to the itchy nature of the hives. Despite a number of treatment options on the market, some patients have struggled to control CSU with urticaria medication such as H1-/H2-antihistamines or montelukast. Novartis said that two-thirds of patients still have severe disease activity and more than half reporting a very large effect of CSU on their life.

Eric Hughes, global development unit head in immunology, hepatology and dermatology, said the company is committed to using its “strong heritage and expertise” in immuno-dermatology to “reimagine and discover potential new treatments” that will benefit patients who need relief from various conditions. Launching the Phase III trials with ligelizumab will honor that commitment, Hughes said.

Ligelizumab is a high-affinity monoclonal anti-IgE antibody. The Phase III studies are designed to establish efficacy and safety of ligelizumab in adolescents over the age of 12 and adult patients with CSU who remain symptomatic despite the use of H1-antihistamines. Both the PEARL 1 and PEARL 2 trials are multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group studies that will be conducted in 48 countries including the U.S., Germany and Japan.

In the Phase IIb placebo-controlled trial, ligelizumab demonstrated “a clear dose-response relationship, and improvements” over Xolair (omalizumab. Xolair has been approved as an add-on treatment for CSU. Novartis said Xolair, which was developed by Genentech and marketed outside the United States by Novartis, is the only therapy recommended by the global guideline on chronic urticaria. In the trial, Novartis said Ligelizumab achieved rapid onset of action and improved and sustained efficacy in CSU patients, whose symptoms are not adequately controlled by H1-antihistamines.

Marcus Maurer, director of research at the Department of Dermatology and Allergy at Allergie-Centrum-Charité of the Charité-Universitätsmedizin in Berlin, Germany, said that CSU has a significant impact on the lives of patients.

“Despite existing treatment options, too many people continue to struggle with the debilitating and potentially painful symptoms of CSU. Advancing ligelizumab to Phase III is encouraging news for physicians and patients who have difficulty in controlling symptoms,” Maurer said in a statement.

Last year Novartis earned $920 million from sales of Xolair. Genentech snagged $1.75 billion, Reuters reported this morning.

Novartis isn’t the only company to focus some R&D on CSU. Genentech, a subsidiary of Roche, is developing fenebrutinib for CSU, as well as rheumatoid arthritis and systemic lupus erythematosus. Fenebrutinib is currently in Phase II. India’s Glenmark Pharmaceuticals is also developing a biosimilar to Xolair, Reuters reported.



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