Novartis advances urticaria med to Phase 3 based on strong Phase 2 data

• PEARL 1 and PEARL 2, the largest pivotal trials to date in chronic spontaneous urticaria (CSU), will enroll more than 2,000 CSU patients[1],[2]
• Ligelizumab (QGE031), a monoclonal antibody, is being developed as a treatment option for CSU patients whose symptoms are inadequately controlled by H1-antihistamines[3]
• In a head-to-head study, ligelizumab showed improvements over Xolair® (omalizumab) in CSU patients[4]

Novartis, a leader in immuno-dermatology, announced today the initiation of Phase III trials for ligelizumab (QGE031) – a high-affinity monoclonal anti-IgE antibody – in chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines[1],[2]. Phase III studies PEARL1 and PEARL 2 are planned to include more than 2,000 CSU patients[1],[2].

‘CSU has a big impact on patients’ lives,’ said Marcus Maurer, MD, Professor of Dermatology and Allergy and Director of Research at the Department of Dermatology and Allergy, Allergie-Centrum-Charité of the Charité-Universitätsmedizin in Berlin, Germany. ‘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.’

Results from the placebo- and active-controlled Phase IIb trial showed that ligelizumab met the primary endpoint by demonstrating a clear dose-response relationship, and improvements over Xolair^® (omalizumab) in CSU patients[4]. Ligelizumab achieved rapid onset of action and improved and sustained efficacy in CSU patients, whose symptoms are not adequately controlled by H1-antihistamines[4].

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-advances-ligelizumab-QGE031-in-urticaria-to-Phase-III-on-basis-of-strong-Phase-II-head-27701109/