Novartis has released new data from two Phase III clinical trials confirming the sustained efficacy and long-term safety of remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, in treating chronic spontaneous urticaria (CSU).

The findings comprise data from the REMIX-1 and REMIX-2 studies, which indicated significant and consistent symptom improvement in remibrutinib-treated patients over 52 weeks.

The studies revealed that remibrutinib provided significant symptom relief compared to placebo, as previously demonstrated at week 12, with these results being reaffirmed at week 24.

This included improvements in weekly urticaria activity score (UAS7), itch severity score (ISS7), and hive severity score (HSS7).

Patients initially receiving a placebo experienced symptom improvement within the first week of transitioning to remibrutinib at week 24, with these responses sustained through the study’s conclusion.

By week 52, almost half of the patients achieved complete freedom from itch and hives.

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The safety profile of remibrutinib was found to be favourable and consistent throughout the 52-week trial period.

Adverse events, serious adverse events (AE), and treatment discontinuations due to adverse events were similar between the remibrutinib and placebo groups during the initial 24-week period.

No serious AEs reported were linked to the trial drug.

Beyond CSU, remibrutinib is under investigation for several other immune-mediated conditions, having already met its primary endpoint in a Phase II study for hidradenitis suppurativa.

It is also being explored as a potential treatment for food allergy, chronic inducible urticaria, and multiple sclerosis.

With these promising results, Novartis plans to seek global health authority approvals for remibrutinib in CSU starting in the second half of this year.

Novartis immunology, development global head Angelika Jahreis said: “Urticaria is a disease that significantly impacts patients’ quality of life and there is an urgent need for new treatment options.

“The 52-week REMIX-1 and REMIX-2 Phase III data are significant as many patients who had moderate to severe urticaria at study start were completely free of itch and hives after 52 weeks of treatment and remibrutinib, a highly selective oral BTK inhibitor, continued to be well tolerated. These exciting long-term data will be submitted to global health authorities later this year.”

The latest development comes after Novartis unveiled interim results from the Phase III ALIGN clinical trial where atrasentan showed to reduce proteinuria in Immunoglobulin A nephropathy (IgAN) patients.