Novartis’ remibrutinib met all the primary and secondary endpoints at 12 weeks in Phase III REMIX-1 and REMIX-2 trials in adults with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.

Remibrutinib is a selective Bruton’s tyrosine kinase (BTK) inhibitor. It acts by stopping histamine release by blocking the BTK cascade. The histamine release is responsible for chronic spontaneous urticaria symptoms such as itching, hives, and swelling.

Chronic spontaneous urticaria, also known as chronic hives, is a skin condition of unknown cause that causes red, raised, and itchy hives that are occasionally painful. These hives last for six weeks or more and are managed symptomatically with anti-histamines, antipruritic, and anti-inflammatories.

The data from the REMIX-1 and REMIX-2 trials (NCT05030311 and NCT05032157) was presented at the 2023 American College of Allergy, Asthma and Immunology Scientific Meeting in Anaheim, California, from 9 to 13 November.

Novartis is planning to apply for global regulatory submissions in 2024, as per the 9 November press release. Remibrutinib is forecasted to generate $237m in 2034 in US sales, as per GlobalData’s Expiry model.

GlobalData is the parent company of Clinical Trials Arena.

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Phase III trial data

The two randomised, multicentre, placebo-controlled Phase III studies evaluated remibrutinib in adults with CSU whose symptoms are inadequately controlled by second-generation H1-antihistamines.  The enrolled participants will continue the treatment for up to Week 52 with an option to continue in a long-term extension trial.

Significant change at 12 weeks from baseline was seen in the remibrutinib treatment group on the weekly urticaria activity score (UAS7), itch (ISS7) and hives (HSS7), compared to placebo. One-third of the participants achieved complete absence of itch and hives at 12 weeks.

The pooled safety analysis from the two REMIX studies showed comparable safety profiles, with 64% and 64.7% overall safety event rates for treatment and placebo groups, respectively. Commonly observed adverse events were infections and liver function test abnormalities, namely liver transaminase elevation.

Other drugs in development for CSU include Sanofi and Regeneron’s monoclonal antibody, Dupixent (dupilumab), which demonstrated a 63% decline in itch severity in Phase III trial within the paediatric population (aged six years or older).