Novartis’ remibrutinib is a highly selective potent oral BTK inhibitor being analysed for being developed in various clinical and early settings. Credit: © Novartis.

Novartis has reported positive Phase IIb clinical trial data where remibrutinib (LOU064) showed fast and efficient disease control in inadequately controlled chronic spontaneous urticaria (CSU) patients.

Remibrutinib is a highly selective potent oral Bruton’s tyrosine kinase (BTK) inhibitor.

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The dose-finding, randomised, double-blind, placebo-controlled Phase IIb trial analysed the efficacy and safety of remibrutinib over 12 weeks in 311 subjects with at least moderately active CSU.

These subjects were poorly controlled by second-generation H1-antihistamines.

Participants were randomised to receive either varying oral doses of remibrutinib or placebo.

The trial met the primary goal with remibrutinib, showing a statistically significant dose-response against placebo with respect to change from baseline (CFB) in urticaria activity score (UAS7) at the fourth week.

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All remibrutinib doses offered substantial improvements related to CFB in UAS7 at week four and week 12 and showed a quick improvement as of week one.

More subjects on remibrutinib attained a complete control with the absence of hives and itchiness, or well-controlled disease until week 12 versus placebo.

The inhibitor demonstrated a favourable safety profile and beneficial tolerability across all the tested doses without any dose-dependent pattern observed.

Novartis immunology, hepatology and dermatology development unit global head Angelika Jahreis said: “Up to 1% of the world’s population is affected by CSU and we are proud of our contribution to advancing treatment.

“The fast-onset of control achieved with this novel oral agent in patients with previously inadequately-controlled CSU is compelling, and we are excited to rapidly develop remibrutinib.”

The Phase III trials in CSU are anticipated to commence subject enrolment by the end of this year, the company noted.

Last month, Novartis decided to discontinue the CIRRUS-1 trial of experimental compound CFZ533 (iscalimab) in kidney transplant patients due to reduced efficacy.