[Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1)

Core Insights - Roche announced that the pivotal Phase III study (FENhance 1) of fenebrutinib in relapsing multiple sclerosis (RMS) met its primary endpoint, showing a 51% reduction in annualized relapse rate (ARR) compared to teriflunomide over at least 96 weeks of treatment [1][8] - The results from FENhance 1 are consistent with FENhance 2, which showed a 59% reduction in ARR, indicating a profound benefit on relapsing and progressive disease biology [1][3][8] - Secondary endpoints in both RMS studies demonstrated statistically significant reductions in brain lesions, with favorable trends observed in all progression endpoints for fenebrutinib [1][3] Study Details - FENhance 1 and 2 are Phase III multicenter, randomized, double-blind studies involving 1,497 adult patients with RMS, comparing fenebrutinib to teriflunomide [7] - Participants were randomized 1:1 to receive either oral fenebrutinib twice daily or oral teriflunomide once daily for at least 96 weeks [7] - The primary endpoint was ARR, while secondary endpoints included MRI lesion counts and confirmed disability progression [8][9] Safety Profile - Liver transaminase elevations in both RMS studies were comparable to teriflunomide, with one Hy's Law case reported in each treatment arm, both of which were asymptomatic and resolved after discontinuation [4] - In the FENhance studies, one fatal case was reported in the teriflunomide arm and eight in the fenebrutinib arms, with further analyses ongoing to understand these findings [5] Mechanism of Action - Fenebrutinib targets B cells and microglia, controlling acute inflammation and addressing chronic damage that drives long-term disability progression [6][11] - It is a non-covalent BTK inhibitor designed for high potency, selectivity, and reversibility, allowing it to cross the blood-brain barrier and target chronic inflammation [12] Future Plans - Full data from the FENhance 1 and 2 studies will be presented at the American Academy of Neurology (AAN) Annual Meeting 2026 and submitted to regulatory authorities alongside data from the FENtrepid study [2]