Novartis has announced positive topline results from its phase 3 REMODEL-1/-2 trials of remibrutinib in relapsing multiple sclerosis. Remibrutinib, a highly selective and potent oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrated superiority versus teriflunomide in reducing annualised relapse rate (ARR) and inflammatory brain lesions with a favourable safety profile.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterised by myelin destruction and axonal damage in the brain, optic nerves and spinal cord. MS, which affects nearly three million people worldwide, can be characterised into three main types: non-active secondary progressive (SPMS), primary progressive (PPMS) and relapsing MS (RMS).
RMS is the most common form and includes clinically isolated syndrome (CIS), relapsing-remitting (RRMS) and active SPMS. The various forms of MS are distinguished by how the disease presents and progresses, including whether patients experience relapses, worsening disability over time or a combination of both.
The results of the REMODEL trials establish remibrutinib as a BTK inhibitor that achieved significant reductions in annualised relapse rate across two phase 3 trials in adults with relapsing multiple sclerosis (RMS).
Remibrutinib demonstrated clinically meaningful reductions versus teriflunomide in key secondary endpoints related to disability progression, with a positive trend in three-month confirmed disability progression and nominal significance in 6-month confirmed disability progression in a preplanned combined analysis of REMODEL-1/-2.
The safety profile in REMODEL-1/-2 was consistent with the broader development programme of remibrutinib comprising more than 4,500 clinical trial participants in multiple indications. Remibrutinib was well tolerated and continues to demonstrate no liver safety signal.
Shreeram Aradhye, President, Development, and Chief Medical Officer of Novartis, said: “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 underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile.”