Swiss drug major Roche has reported that its investigational multiple sclerosis therapy fenebrutinib has met the primary endpoint in a Phase III trial in people with primary progressive multiple sclerosis, a rare and disabling form of the disease with limited treatment options. The company announced that the oral Bruton tyrosine kinase inhibitor reduced the risk of worsening disability compared with its own approved monoclonal antibody Ocrevus, which is currently the only licensed therapy for primary progressive multiple sclerosis.
Phase III study shows a reduction in disability progression
In the Phase III study, fenebrutinib reduced the risk of disability worsening by 12 percent compared with Ocrevus in patients with primary progressive multiple sclerosis. Roche reported that the separation between treatment curves emerged after 24 weeks of therapy, indicating an early and sustained clinical effect on disease progression.
Additional analyses from the trial suggested that fenebrutinib may offer benefits in upper limb function, an important measure of independence and quality of life in people living with primary progressive multiple sclerosis. Primary progressive multiple sclerosis is the least common form of multiple sclerosis and is characterised by a steady accumulation of disability from disease onset, rather than distinct relapses and remissions.
First PPMS therapy candidate to show progress in over a decade
Roche noted that fenebrutinib is the first experimental therapy in more than ten years to demonstrate a reduction in disability progression in a dedicated primary progressive multiple sclerosis study. This positions the drug as a potential new option in an area of high unmet need where clinicians currently rely primarily on Ocrevus for disease modifying treatment.
The company plans to move toward global regulatory submissions for fenebrutinib once it has additional Phase III data from an ongoing trial in relapsing forms of multiple sclerosis, expected in the first half of 2026. If the broader development program is successful, fenebrutinib could expand Roche’s multiple sclerosis portfolio and offer neurologists a new mechanism-based oral therapy for both primary progressive and relapsing forms of the disease.
