Novartis has reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials evaluating remibrutinib in adults with relapsing multiple sclerosis (RMS).
The oral Bruton’s tyrosine kinase (BTK) inhibitor showed better results than teriflunomide in reducing annualized relapse rates (ARR) and inflammatory brain lesions. The company said the findings support remibrutinib as a potential high-efficacy oral treatment for people living with RMS.
Across both Phase III trials, remibrutinib achieved significant reductions in annualized relapse rates compared with teriflunomide. The studies also showed positive results on measures linked to disability progression.
In a preplanned combined analysis of REMODEL-1 and REMODEL-2, patients treated with remibrutinib showed a positive trend in three-month confirmed disability progression (3mCDP). The treatment also achieved nominal statistical significance for six-month confirmed disability progression (6mCDP).
The safety results were consistent with the wider remibrutinib clinical development program, which includes more than 4,500 participants across multiple diseases and clinical studies.
Novartis said remibrutinib was generally well tolerated in the REMODEL trials. Importantly, the company reported no liver safety signal, including no cases that met Hy’s Law criteria, a regulatory measure used to identify potential serious drug-related liver injury.
Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, said the results highlight the potential of remibrutinib to provide strong relapse prevention while addressing the need for oral treatments with a favorable safety profile.
Multiple sclerosis is a chronic neurological disease in which the immune system attacks the central nervous system. Relapsing MS is characterized by episodes of new or worsening symptoms, followed by periods of recovery.
Novartis plans to present detailed results from the REMODEL-1 and REMODEL-2 studies as a late-breaking presentation at MSToronto2026. The company also plans to hold an investor call following the conference presentation.
Following the positive Phase III results, Novartis intends to seek regulatory approval for remibrutinib for relapsing multiple sclerosis in markets worldwide.
If approved, remibrutinib could add a new oral treatment option for patients with relapsing multiple sclerosis, particularly those seeking therapies that combine strong disease control with a favorable safety profile.