Novartis a step closer to filing remibrutinib in urticaria as long-term data emerge
31 May 2024
Clinical ResultPhase 2Phase 3
Novartis is gearing up to file marketing applications in the second half of the year for its BTK inhibitor remibrutinib in chronic spontaneous urticaria (CSU) following the announcement on Friday of long-term findings from two Phase III studies. The results are scheduled to be presented at the European Academy of Allergy and Clinical Immunology (EAACI) congress.
The identical REMIX-1 and REMIX-2 trials were designed to investigate twice-daily remibrutinib 25 mg compared with placebo in 470 and 455 adults, respectively, with CSU inadequately managed by second-generation H1-antihistamines. In top-line results released in August last year, the studies met their primary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity as early as week two.
Efficacy sustained
The new 52-week data further demonstrated significant improvements in weekly scores for urticaria activity (UAS7), itch severity (ISS7), and hive severity (HSS7) with remibrutinib versus placebo, consistent with the findings observed at week 12 and corroborated at week 24. Furthermore, more than half of the patients were completely free of itch and hives at week 52.
The company also noted that placebo recipients who were switched to remibrutinib at week 24, showed responses as early as the first week after the transition, which persisted until the study's completion at 28 weeks.
Angelika Jahreis, global head of development for immunology at Novartis, said “urticaria is a disease that significantly impacts patients' quality of life and there is an urgent need for new treatment options,” adding that many of the patients with moderate-to-severe disease at baseline could attain long-term relief from itch and hives with remibrutinib.
Safety concerns addressed
The company added that remibrutinib showed favourable safety and tolerability for up to 52 weeks, with no serious adverse events deemed related to the drug. Increases in liver transaminases were balanced across the remibrutinib and placebo groups, with all occurrences being asymptomatic, temporary and reversible.
In April last year, Novartis had clarified that there was no evidence of liver toxicity with remibrutinib, which had been a concern with other BTK inhibitorsBTK inhibitors, including Merck KGaA’s evobrutinib, Sanofi’s tolebrutinib and Roche’s fenebrutinib.
Apart from CSUCSU, remibrutinib is being investigated for hidradenitis suppurativa, where it hit the main goal in a Phase II study, alongside food allergy, chronic inducible urticaria, and multiple sclerosis.
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