Experimental MS drug bests approved therapy in cutting relapses in 2 trials
Developer says it will seek approval globally for new treatment
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In two large clinical trials, the experimental drug remibrutinib was shown to work better than an approved therapy at reducing MS relapses. (Image from iStock)
- In two large, late-stage trials, the experimental oral drug remibrutinib outperformed the approved therapy Aubagio in cutting MS relapse rates.
- The oral drug candidate reduced average yearly flare rates and led to fewer lesions on MRI scans in people with relapsing MS.
- Based on these positive results, developer Novartis said it plans to seek remibrutinib's approval worldwide.
An experimental oral drug called remibrutinib outperformed the approved therapy Aubagio (teriflunomide) in reducing disease flare rates in two large, late-stage clinical trials involving people with relapsing forms of multiple sclerosis (MS).
That’s according to top-line data — the studies’ first results — announced by remibrutinib’s developer Novartis, sponsor of the pair of Phase 3 trials, which together enrolled about 2,000 people with MS across the globe. The new data show that remibrutinib cut average yearly relapse rates and led to fewer lesions on MRI scans.
Based on these results, Novartis announced that it will submit applications to regulatory authorities worldwide seeking the drug’s approval as a treatment for relapsing MS.
“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention,” Shreeram Aradhye, MD, president of development and chief medical officer at Novartis, said in a company press release, which noted that both trials “met their primary endpoint,” or the studies’ main goal.
Novartis stated that it now “plans to seek regulatory approval for remibrutinib in [relapsing] MS globally.”
MS is a chronic disorder marked by inflammation that damages healthy cells in the brain and spinal cord. In most patients, the disease is marked by relapses — flare-ups in which symptoms suddenly worsen due to new inflammatory activity.
There are a variety of disease-modifying therapies available to help prevent flares in people with relapsing MS, each with unique profiles in terms of effectiveness, safety, and convenience.
Still, Aradhye noted a need for new drugs that can “slow disability progression, while maintaining a favorable safety profile” — and also cut disease flares.
Trials compared 2 drugs for MS: remibrutinib and Aubagio
Remibrutinib is a BTK inhibitor, meaning it’s designed to block the activity of Bruton’s tyrosine kinase (BTK), an enzyme that plays key roles in driving the activity of certain inflammatory immune cells implicated in MS.
The identical Phase 3 trials, REMODEL-1 (NCT05147220) and REMODEL-2 (NCT05156281), tested the therapy against Aubagio, another oral drug, approved in more than 80 countries for people with MS. Each trial enrolled about 1,000 participants globally.
In both studies, the main goal was to determine whether remibrutinib outperformed Aubagio in reducing relapse rates over up to 30 months, or about 2.5 years, of follow-up.
According to Novartis, each trial met that goal, with data showing that average yearly relapse rates were significantly lower with remibrutinib. The investigational therapy also outperformed Aubagio at reducing rates of inflammatory lesions as seen on MRI, and data suggest that patients given remibrutinib were less likely to experience worsening disability, Novartis said.
The positive REMODEL [trial] results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with [relapsing] MS.
Novartis also reported that safety data were positive and largely in line with previous remibrutinib studies. The company did not provide details on any of the results, noting that in-depth data will be presented at MSToronto2026, a scientific conference taking place in October.
“The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with [relapsing] MS with a differentiated benefit-risk profile,” Aradhye said.
In addition to remibrutinib, several other BTK inhibitors have previously been tested in late-stage clinical trials for relapsing forms of MS. In Phase 3 trials, Genentech‘s fenebrutinib was shown to work better than Aubagio at reducing relapse rates, while Sanofi‘s tolebrutinib did not outperform Aubagio in this measure.
“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,” Aradhye said.
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