In a recent press release, Novartis has reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials, showing that the investigational oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib significantly reduced disease activity in patients with relapsing multiple sclerosis (RMS) compared with teriflunomide.
The twin studies met their primary endpoint, demonstrating a statistically significant reduction in annualized relapse rate (ARR) among adults receiving remibrutinib. The oral therapy also outperformed teriflunomide across key secondary measures, including reductions in inflammatory brain lesions detected by magnetic resonance imaging (MRI).
According to Novartis, remibrutinib showed encouraging effects on disability progression. In a preplanned pooled analysis of both studies, treatment was associated with a favorable trend toward reducing three-month confirmed disability progression (3mCDP) and achieved nominal statistical significance for six-month confirmed disability progression (6mCDP), suggesting potential benefits beyond relapse control.
Safety findings were also notable. The company reported that remibrutinib was generally well tolerated, with no apparent liver safety signal observed during the trials. No cases met Hy’s Law criteria, a benchmark used to identify serious drug-induced liver injury. The safety profile was consistent with previous studies of remibrutinib, which has been evaluated in more than 4,500 participants across multiple clinical programs.
“Despite advances in treatment, there remains a need for effective oral therapies that balance strong disease control with an acceptable safety profile,” said Shreeram Aradhye, MD, President of Development and Chief Medical Officer at Novartis, in a company statement.
A Potential New BTK Inhibitor Option in MS
Remibrutinib is a highly selective BTK inhibitor designed to modulate immune activity by targeting both B cells and components of the innate immune system involved in neuroinflammation. BTK inhibitors have emerged as a promising class of therapies for multiple sclerosis because of their potential to address inflammatory mechanisms linked to disease progression while offering the convenience of oral administration.
The REMODEL program enrolled approximately 2,000 adults with RMS who had evidence of recent disease activity. Participants were randomized to receive either remibrutinib 100 mg or teriflunomide in a double-blind treatment period lasting up to 30 months, followed by a long-term extension phase.
In addition to relapse outcomes, investigators assessed MRI lesion activity, confirmed disability progression, serum neurofilament light chain concentrations, and the proportion of patients achieving no evidence of disease activity (NEDA-3).
Regulatory Plans
Novartis plans to present detailed results from REMODEL-1 and REMODEL-2 as a late-breaking presentation at MSToronto2026. The company also announced its intention to seek regulatory approvals for remibrutinib as a treatment for RMS in markets worldwide.
The drug has already been approved in the United States and Europe for chronic spontaneous urticaria under the brand name Rhapsido®, providing regulators with prior clinical experience regarding its safety profile.
If approved for multiple sclerosis, remibrutinib could expand the range of oral, high-efficacy treatment options available to patients living with relapsing forms of the disease, which affects nearly 3 million people globally.
