Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Monday that its Phase III FENhance 1 study in relapsing multiple sclerosis (RMS) met the primary endpoint, showing that fenebrutinib reduced the annualised relapse rate by 51% compared to teriflunomide over at least 96 weeks.

These results are consistent with the FENhance 2 study, which showed a 59% reduction in relapses. Secondary endpoints demonstrated statistically significant reductions in brain lesions, with favourable trends across progression measures.

Fenebrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, is designed to penetrate the central nervous system, targeting B cells and microglia to address both relapsing and progressive disease biology. Positive results from FENhance 1 follow prior success in FENhance 2 (RMS) and FENtrepid (primary progressive MS or PPMS), completing the pivotal programme. Liver transaminase elevations were comparable to teriflunomide, with isolated, asymptomatic Hy's Law cases resolving after drug discontinuation.

Data from all three studies will be submitted to regulatory authorities and presented at the 2026 American Academy of Neurology Annual Meeting.

Fenebrutinib has the potential to become the first oral, high-efficacy BTK inhibitor for both RMS and PPMS.