Novartis announced positive topline results from two Phase III trials evaluating remibrutinib in adults with relapsing multiple sclerosis, with both studies meeting their primary endpoint and showing significant reductions in annualized relapse rates compared with teriflunomide.
The identical REMODEL-1 and REMODEL-2 trials also demonstrated superiority for remibrutinib across all key secondary endpoints within each trial, including reductions in MRI brain lesions.
A preplanned combined analysis showed a clinically meaningful delay in disability progression, including a positive trend in three-month confirmed disability progression and nominally significant six-month confirmed disability progression.
Remibrutinib also demonstrated a favorable safety profile consistent with the broader development program, which includes more than 4,500 clinical trial participants across multiple indications.
Novartis said there was no liver safety signal, including no cases meeting Hy’s Law criteria.
Novartis plans to present detailed REMODEL-1 and REMODEL-2 results as late-breaking data at MSToronto2026 and intends to seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.
Remibrutinib is a highly selective oral 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 drug is also being investigated in the REMASTER Phase III program for secondary progressive multiple sclerosis and in other immune-mediated diseases.
Remibrutinib 25 mg is already approved as Rhapsido in the United States and European Union for adults with chronic spontaneous urticaria.
REMODEL-1 and REMODEL-2 enrolled approximately 2,000 patients globally with recent disease activity. Participants were randomized to receive remibrutinib 100 mg or teriflunomide.
The studies include a double-blind core portion lasting up to 30 months followed by an open-label extension of up to five years.
KEY QUOTE:
“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable 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. Building on our long-standing commitment to advancing care in MS, these findings reinforce our continued ambition on driving innovation in this space and delivering therapies that address the evolving needs of people living with MS.”
Shreeram Aradhye, President, Development, and Chief Medical Officer of Novartis
