Results of phase 3 trials could lead to the approval of remibrutinib to provide more effective and controlled treatment of chronic spontaneous urticaria than H1-antihistamines.
Novartis announced positive top-line results from the phase 3 REMIX-1 and REMIX-2 studies evaluating remibrutinib (LOU064; Novartis) in patients with chronic spontaneous urticaria (CSU) whose symptoms were inadequately controlled by H1-antihistamines, according to a statement released by the company.
Remibrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor discovered and developed by Novartis that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts, and swelling.
CSU is the term used for chronic hives that last for 6 weeks or longer, in which the underlying cause is internal and not due to any external exposure to allergens. It affects approximately 40 million people worldwide and is characterized by the sudden appearance of itchy hives and deep tissue swelling. CSU affects all ages, but most frequently occurs in those between 20 and 40 years of age, with women affected almost twice as often as men.
REMIX-1 and REMIX-2 were both global, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies. REMIX-1 consisted of 470 participants, whereas REMIX-2 had 455 participants. The trials were designed to establish the safety, efficacy, and tolerability of remibrutinib in adult participants with CSU.
Each study met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, which demonstrates clinically meaningful and statistically significant improvements in disease activity.
Additionally, remibrutinib demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at week 2 in the REMIX-1 and REMIX-2 studies, which will continue until week 52 of the trial. Overall, the results support the potential of remibrutinib as a new, effective, fast-acting oral treatment option for patients uncontrolled by first-line H1-antihistamines, according to Novartis.
Although designated as the first-line treatment in CSU, H1-antihistamines inadequately control CSU in approximately 60% of patients who continue to live with symptoms. Injectable biologic therapies are an effective option for those whose CSU is uncontrolled by antihistamines, but less than 20% of patients worldwide are treated with them.
“CSU is a distressing and unpredictable disease, and patients urgently need effective, convenient and well-tolerated treatments that can provide rapid and sustained relief from the relentless itching and deep tissue swelling that greatly impact their daily lives,” said Shreeram Aradhye, MD, president of Global Drug Development and chief medical officer at Novartis, in a press release. “These positive top-line results from the Phase III REMIX studies confirm that remibrutinib, a highly selective BTK inhibitor, has the potential to be a first-in-class, oral treatment for people living with CSU whose symptoms are refractory despite use of antihistamines.”
Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria. Novartis. Press release. Accessed August 9, 2023. Published August 9, 2023. https://www.novartis.com/news/media-releases/novartis-remibrutinib-phase-iii-trials-met-their-primary-endpoints-and-showed-rapid-symptom-control-chronic-spontaneous-urticaria