Novartis has reported that its pivotal Phase III RemIND trial, evaluating oral remibrutinib in chronic inducible urticaria (CIndU), achieved the primary endpoint.
The study met this endpoint for the three most prevalent CIndU types: cold urticaria, cholinergic urticaria, and symptomatic dermographism, with notably higher complete response rates compared to placebo at week 12.
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The randomised, global, multi-centre, placebo-controlled, double-blind, parallel-group Phase III trial is assessing the safety, tolerability and efficacy of remibrutinib in adults with CIndU who have not responded adequately to H1-antihistamines.
Its main outcome measured was the proportion of complete responders at week 12, evaluated through provocation tests for each of the three CIndU subtypes.
Novartis has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for remibrutinib in symptomatic dermographism.
The company plans to submit the full dataset to global health authorities in the coming months and to present RemIND findings at upcoming medical congresses.
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By GlobalDataNovartis immunology development global head Angelika Jahreis said: “The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU).
“Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.”
Remibrutinib is a highly selective Bruton’s tyrosine kinase (BTK) inhibitor that blocks the pathway responsible for histamine release.
By limiting the release of histamine, it helps to reduce symptoms like hives and swelling linked to CIndU. In China and the US, remibrutinib received approval for adult CSU patients who do not respond to H1-antihistamines.
The therapy is under further investigation for other immune-mediated conditions, including food allergy and hidradenitis suppurativa, as well as neuroscience indications.
Earlier this week, Novartis announced final data from the Phase III ALIGN study, highlighting that Vanrafia (atrasentan) slowed kidney function decline in adults with immunoglobulin A nephropathy (IgAN).
