- Phase III FENtrepid results show fenebrutinib met its primary endpoint of non-inferiority to Ocrevus in PPMS.
- Fenebrutinib reduced disability progression risk by 12% compared to Ocrevus at 24 weeks.
- Regulatory submission for fenebrutinib in PPMS and RMS is planned after Phase III FENhance 1 readout, expected mid first half of 2026.
Study Results
Late-breaking Phase III FENtrepid results presented at ACTRIMS demonstrate that the investigational drug fenebrutinib met its primary endpoint of non-inferiority compared to Ocrevus in reducing disability progression in primary progressive multiple sclerosis (PPMS). Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, the only approved medicine for PPMS, with curves separating as early as 24 weeks.
Potential Benefits
Additional analysis indicated potential benefits of fenebrutinib in improving upper limb function. The treatment effect on confirmed disability progression was consistent across patient subgroups and throughout the treatment duration.
Future Plans
Fenebrutinib is positioned to become a first-in-class oral, brain-penetrant BTK inhibitor for both PPMS and relapsing multiple sclerosis (RMS). Regulatory submission for fenebrutinib in both PPMS and RMS is planned following the Phase III FENhance 1 readout, which is expected in the mid first half of 2026.
