Novartis Announces Positive Topline Results from Two Pivotal Phase 3 Trials of Remibrutinib in Chronic Spontaneous Urticaria

▎WuXi

Edited by Kant Content Team

Novartis today announced updated positive data from the pivotal Phase 3 REMIX-1 and REMIX-2 trials, which evaluated the efficacy of its investigational Bruton's tyrosine kinase (BTK) inhibitor remibrutinib in patients with chronic spontaneous urticaria (CSU) whose symptoms were not adequately controlled by H1 antihistamines. The analysis showed,Compared with placebo, remibrutinib demonstrated a clinically meaningful and statistically significant reduction in urticaria symptoms. As early as week 2, remibrutinib treatment significantly improved patients' symptom control, which persisted until week 12.The REMIX-1 and REMIX-2 trials are currently underway.Novartis is scheduled to obtain the final data at 52 weeks and complete the regulatory submission by 2024.

Trial analysis shows,Remibrutinib Achieves All Primary and Secondary Endpoints at Week 12. Compared with placebo, remibrutinib demonstrates superiority in the change from baseline in weekly urticaria activity (UAS7), itch severity (ISS7), and hives severity (HSS7) scores.Compared with placebo, as early as the 2nd week, a significantly greater number of patients achieved well-controlled disease (UAS7≤6), and the efficacy persisted until the 12th week, with approximately one-third of patients being completely free of pruritus and urticaria symptoms at the 12th week.

In two studies, remibrutinib demonstrated good tolerability and safety profiles, with an overall adverse event rate comparable to placebo.

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Molecular structure of emibrutinib (Source: PubChem)

Remibrutinib is a potential "best-in-class" BTK inhibitor.It can covalently bind to the BTK enzyme in B cells and myeloid cells, strongly inhibit BTK activity while reducing systemic drug exposure, and lower the risk of adverse events and drug interactions.

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