Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has announced positive data from the Phase III trials for remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, which is under development to treat chronic spontaneous urticaria (CSU). The Phase III REMIX-1 and REMIX-2 studies successfully met all primary and secondary endpoints, showing rapid and clinically significant improvements in urticaria disease activity scores.
A Potential Breakthrough in Urticaria Treatment
Novartis aims to introduce the first new treatment for urticaria in a decade, offering an alternative for the 60% of patients who do not find relief from symptoms using antihistamines. CSU, also known as chronic hives, lasts for six weeks or longer, with internal causes rather than external allergens.
Design and Results of the REMIX Trials
REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) are globally designed, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III studies. They enrolled 470 and 455 adult CSU sufferers, respectively, focusing on patients unresponsive to antihistamine treatment. Novartis reports that remibrutinib demonstrated clinical effects within two weeks of treatment,展现了 favorable safety, and by Week 12, achieved the primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7). The trials will continue for 52 weeks, with full data expected in 2024.
Broad Development Program for Remibrutinib
In addition to urticaria, remibrutinib is under development for a variety of immune-mediated conditions, including multiple sclerosis, hidradenitis suppurativa, and food allergy.-Fineline Info & Tech
