Benzinga | Dec 20, 2021 04:49AM EST

Novartis Announced Top-line Results from PEARL 1 and PEARL 2 Phase III Studies in Chronic Spontaneous Urticaria Met Their Primary Endpoints of Superiority for Ligelizumab vs Placebo at Week 12, But Not vs Omalizumab

Novartis today announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab1.

"We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "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."

Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.

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 weeks2,3 and affects up to 1% of the population at any one time2. Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines4-7.

Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control8,9.