Novartis reports remibrutinib Phase 3 trials met their primary endpoints

Novartis announced positive top-line results from the Phase III REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg b.i.d., a Bruton’s tyrosine kinase inhibitor, in patients with chronic spontaneous urticaria, or CSU, whose symptoms are inadequately controlled by H1-antihistamines1. Both Phase III studies met their primary endpoint of absolute change from baseline in weekly urticaria activity score at Week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity. The studies will continue until Week 52. Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at Week 2 in the REMIX-1 and REMIX-2 studies. “These data support the potential of remibrutinib as a new, effective and fast-acting oral treatment option for those uncontrolled by first-line H1-antihistamines. Novartis will present the REMIX data at an upcoming medical meeting and intends to submit to global health authorities starting in 2024,” the company said.