By VETTAPHARMA reporter – Derek Roche: Novartis has announced positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials evaluating remibrutinib in adults with relapsing multiple sclerosis.
The trials met their primary endpoint, with remibrutinib demonstrating a significant reduction in annualized relapse rate compared with teriflunomide. Remibrutinib also showed superiority over teriflunomide across all key secondary endpoints evaluated in each trial, including measures of inflammatory brain lesions.
In a preplanned combined analysis of REMODEL-1 and REMODEL-2, remibrutinib demonstrated a clinically meaningful effect on measures of disability progression. The analysis showed a positive trend in 3-month confirmed disability progression and nominal statistical significance in 6-month confirmed disability progression.
Remibrutinib is an oral, highly selective Bruton’s tyrosine kinase inhibitor that blocks the BTK pathway, reducing activation of B cells and innate immune cells involved in immune regulation and neuroinflammation.
The safety profile observed across the two Phase III trials was consistent with the broader remibrutinib development program, which includes more than 4,500 clinical trial participants across multiple indications. Novartis reported that remibrutinib was well tolerated, with no liver safety signal and no cases meeting Hy’s Law criteria in REMODEL-1 and REMODEL-2.
Clinical Development
REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active-comparator-controlled Phase III studies comparing remibrutinib with teriflunomide in adults with relapsing multiple sclerosis.
Approximately 2,000 participants globally with evidence of recent disease activity were randomized to receive remibrutinib or teriflunomide. The primary endpoint was annualized relapse rate, while key secondary endpoints included disability progression, magnetic resonance imaging lesion measures, serum neurofilament light chain concentration and no evidence of disease activity.
Regulatory Outlook
Novartis plans to present the REMODEL-1 and REMODEL-2 results as a late-breaking presentation at MSToronto2026. The company also plans to seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.
Remibrutinib is already approved in the United States and European Union under the brand name Rhapsido for adults with chronic spontaneous urticaria. Its investigation in multiple sclerosis includes the ongoing Phase III REMODEL program in relapsing multiple sclerosis and the REMASTER program in secondary progressive multiple sclerosis.
Quick FAQs
1. What Did The REMODEL Trials Show?
Both Phase III trials met their primary endpoint, demonstrating significant reductions in annualized relapse rate with remibrutinib versus teriflunomide.
2. What Is Remibrutinib?
Remibrutinib is an oral, highly selective Bruton’s tyrosine kinase inhibitor being investigated across multiple immune-mediated conditions.
3. What Additional Benefits Were Reported?
Remibrutinib showed superiority across key secondary endpoints, including reductions in inflammatory brain lesions. A combined analysis also showed a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression.
4. What Was The Safety Profile?
Novartis reported a favorable safety profile, with no liver safety signal and no cases meeting Hy’s Law criteria in the REMODEL-1 and REMODEL-2 trials.
5. What Happens Next?
Novartis plans to present detailed results at MSToronto2026 and seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.
