Novartis announced positive Phase III results for its oral Bruton’s tyrosine kinase inhibitor, remibrutinib, in two trials for adults with relapsing multiple sclerosis.
Meeting key efficacy targets
The company stated that remibrutinib met its primary endpoint in the REMODEL-1 and REMODEL-2 studies, demonstrating a statistically significant reduction in annualised relapse rate compared to the standard treatment teriflunomide. In these multicentre, double-blind studies, participants also saw fewer magnetic resonance imaging lesions. Both trials showed remibrutinib was superior across key secondary endpoints, including reductions in MRI lesions.
When combining data from both trials, Novartis observed a positive trend in three-month confirmed disability progression. The six-month confirmed disability progression metric showed a nominally statistically significant result. Nearly 2,000 patients across various countries participated in the research, which included participants with an Expanded Disability Status Scale of 0.0 to 5.5. Participants with an Expanded Disability Status Scale of 0.0–5.5 were randomised to receive either remibrutinib or teriflunomide. In addition to the primary endpoint of annualised relapse rate, the trials measured outcomes such as 3mCDP and 6mCDP, as well as several new or enlarging MRI lesions.
For the patients taking part in these studies, the shift to an oral treatment option could mean fewer hospital visits and a different daily routine compared to injectable therapies. The ability to manage the condition with a pill rather than infusions or injections often impacts long-term adherence and quality of life in ways that clinical statistics alone cannot capture.
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Assessing safety and next steps
Novartis reported that the safety profile of remibrutinib in these RMS trials was consistent with previous findings from its development in chronic spontaneous urticaria. Specifically, there were no liver safety signals and no cases meeting Hy’s Law criteria. Novartis reported that remibrutinib’s safety profile in these RMS trials was consistent with earlier studies, including its development in chronic spontaneous urticaria, with no liver safety signal identified and no cases meeting Hy’s Law criteria.
Shreeram Aradhye, the development president and chief medical officer at Novartis, commented on the findings.
“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention and slow disability progression while maintaining a favourable safety profile. The positive REMODEL results highlight the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile.”
Novartis plans to present late-breaking data from the REMODEL trials at MSToronto2026 and intends to seek regulatory submissions for remibrutinib in RMS across multiple regions. The drug is also being investigated in other neurological and immune-mediated conditions. It is already approved under the name Rhapsido for chronic spontaneous urticaria by health authorities in the US and EU.
