- FENhance 1 study showed a 51% reduction in relapses for RMS compared to teriflunomide.
- Data from all three Phase III studies will be submitted to regulatory authorities.
- Full data to be shared at the AAN Annual Meeting 2026.
- Further analyses are ongoing to understand fatal cases in the fenebrutinib arms.
Study Results
The FENhance 1 study demonstrated that fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, reduced relapses by 51% in relapsing multiple sclerosis (RMS) compared to teriflunomide. This aligns with FENhance 2 results, which showed a 59% reduction.
Regulatory Submission
Data from all three Phase III studies, including FENhance 1, FENhance 2, and FENtrepid, will be submitted to regulatory authorities. Full data will also be presented at the American Academy of Neurology (AAN) Annual Meeting 2026.
Safety Profile
In both RMS studies, liver transaminase elevations were comparable with teriflunomide. One Hy’s Law case was reported in each treatment arm, both asymptomatic and resolved after discontinuation. No additional Hy's Law cases were observed across the fenebrutinib clinical development program.
Fatal Cases
In the FENhance 1 and 2 studies, one fatal case occurred in the teriflunomide arm, and eight in the fenebrutinib arms. Further analyses are ongoing to understand these findings.
Mechanism of Action
Fenebrutinib targets B cells and microglia in the immune system. It controls acute inflammation causing relapses and addresses chronic damage driving long-term disability progression. As a non-covalent BTK inhibitor, it is designed for high potency, selectivity, and reversibility, allowing it to act throughout the body and cross the blood-brain barrier to target chronic inflammation in the central nervous system.
