Novartis' Ligelizumab Suffers Setback In Late-Stage Skin Disorder Studies

Novartis AG NVS said that its ligelizumab antibody treatment against recurring hives did not meet the goal of superiority to standard treatment Xolair (omalizumab) in a late-stage study.

• Novartis' PEARL 1 and PEARL 2 Phase 3 studies met the goal for ligelizumab to show higher efficacy against chronic spontaneous urticaria (CSU) compared to placebo at week 12, but not compared to omalizumab.
• CSU is a systemic skin disease characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema, or both for at least six weeks.
• "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, head of global drug development and chief medical officer.
• Full PEARL 1 and 2 Phase 3 data will be made publicly available after study completion in 2H of 2022.
• Novartis recently began Phase 3 studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that previously showed rapid and effective CSU disease control.
• Price Action: NVS shares are down 1.04% at $85.01 during the premarket session on Monday's last check.