KEY POINTS
- Roche’s experimental MS drug fenebrutinib hit its primary endpoint in a Phase III trial for primary progressive MS.
- The drug reduced the risk of disability worsening by about 12% versus current standard treatment.
- Roche plans regulatory submissions after further data from a relapsing MS study.
Swiss pharmaceutical giant Roche said its experimental multiple sclerosis treatment fenebrutinib met the main goal in a late-stage clinical trial for a difficult-to-treat form of the disease.
The Phase III study focused on patients with primary progressive multiple sclerosis (PPMS), a form marked by steadily worsening disability without clear relapses. Fenebrutinib demonstrated a measurable reduction in progression risk compared with Roche’s currently approved therapy.
Results showed fenebrutinib lowered the risk of disability worsening by about 12% relative to Ocrevus, the only standard treatment for PPMS. Separation of treatment outcomes began to appear after roughly six months.
The trial examined a composite measure of confirmed disability progression, which assesses functional decline across walking and upper-limb tests. Additional analysis suggested that fenebrutinib’s effect on upper-limb function was particularly notable.
Roche described the trial result as the first reduction in disability progression seen in PPMS research in more than ten years. The company hopes fenebrutinib could become a new treatment option for patients who have limited therapeutic choices for this MS form.
Fenebrutinib is designed as a small-molecule Bruton’s tyrosine kinase (BTK) inhibitor that can be taken orally. It targets immune cells involved in neuroinflammation, a key driver of MS progression.
Roche’s announcement also highlighted plans to seek regulatory approval once more data are available from a parallel Phase III study in relapsing MS. That additional readout is expected in the first half of 2026.
The regulatory bid could see fenebrutinib positioned as the first BTK inhibitor approved for both major MS forms, should the data support effectiveness and safety.
The PPMS trial success follows earlier results showing fenebrutinib’s potential in relapsing MS and could broaden treatment choices across the MS spectrum.
Analysts and patient advocates have noted that new therapies for progressive MS are rare, making the outcome noteworthy for the medical community. Continued monitoring of safety and long-term benefit will be essential as Roche moves toward regulatory review.
Roche’s pipeline efforts in neuroscience extend beyond MS and include research into other neurological disorders, reflecting a broader focus on chronic conditions with high unmet need.
If approved, fenebrutinib could offer a more convenient oral option compared with existing infusion-based therapies. The potential impact on patient quality of life and disease management could be significant.
