Novartis remibrutinib significantly reduces relapse rates in Phase III relapsing multiple sclerosis studies

Novartis has reported positive topline results from the Phase III REMODEL 1 and REMODEL 2 studies evaluating remibrutinib in adults with relapsing multiple sclerosis.

The oral Bruton’s tyrosine kinase inhibitor met the primary endpoint in both trials by significantly lowering annualized relapse rates compared with teriflunomide. Remibrutinib also showed superiority across all key secondary endpoints within each study, including measures assessing inflammatory brain lesions on MRI.

A preplanned combined analysis of REMODEL 1 and REMODEL 2 also showed clinically meaningful findings related to disability progression. Treatment with remibrutinib produced a positive trend in three month confirmed disability progression and achieved nominal statistical significance for six month confirmed disability progression.

Remibrutinib is a highly selective and potent oral BTK inhibitor. The Phase III findings showed that the therapy significantly reduced relapse rates and inflammatory brain lesions compared with teriflunomide while maintaining a favourable safety profile.

Safety findings from REMODEL 1 and REMODEL 2 were consistent with experience from the broader remibrutinib clinical development programme, which includes more than 4,500 participants across several indications.

The treatment was generally well tolerated and no liver safety signal was identified. No cases meeting Hy’s Law criteria were reported in the two studies.

Shreeram Aradhye, president of Development and chief medical officer at Novartis, said there remains a need for oral treatments that can provide strong relapse control while also slowing disability progression and maintaining a favourable safety profile.

He said the REMODEL findings demonstrate the potential for remibrutinib to become a highly effective oral option for people with relapsing multiple sclerosis, with a differentiated balance of benefits and risks. Aradhye added that the results support Novartis’ continued focus on developing treatments that address changing patient needs in multiple sclerosis.

Novartis plans to present detailed findings from REMODEL 1 and REMODEL 2 as late breaking data at MSToronto2026. The company also intends to hold an investor call following the congress presentation.

The company plans to seek regulatory approvals for remibrutinib in relapsing multiple sclerosis across global markets.

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Related Topics and Keywords

clinical trials, multiple sclerosis, neurology, Novartis, pharma news, Phase 3, remibrutinib