Novartis Phase III RemIND Trial Meets Primary Endpoint for Chronic Inducible Urticaria

Novartis announced topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU). The primary endpoint was met for the three most prevalent types of CIndU, achieving significantly higher complete response rates versus placebo at Week 121.

The trial evaluated remibrutinib in three common CIndU subtypes: symptomatic dermographism, cold urticaria, and cholinergic urticaria. Minor skin pressure, scratching, or rubbing triggers itchy, red, linear wheals in symptomatic dermographism patients. Cold urticaria is triggered by exposure to cold temperatures—air, water, or objects—causing itchy red welts (hives). Cholinergic urticaria is triggered by a rise in body temperature and sweat, causing small, itchy red bumps or wheals.

These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need. "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," said the Global Head of Immunology Development at Novartis.

Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism.

Novartis shares were up 0.98% at $167.80 during premarket trading on Wednesday. The stock is trading at a new 52-week high.