[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

Core Insights - Roche announced that the Phase III study FENhance 2 met its primary endpoint, showing that fenebrutinib significantly reduced the annualised relapse rate (ARR) in patients with relapsing multiple sclerosis (RMS) compared to teriflunomide over at least 96 weeks of treatment [1][8] - The Phase III FENtrepid study demonstrated that fenebrutinib was non-inferior to OCREVUS in delaying disability progression in patients with primary progressive multiple sclerosis (PPMS) over at least 120 weeks [2][8] - Fenebrutinib's results indicate its potential as a leading treatment option for both RMS and PPMS, with a focus on its high efficacy and oral administration [3][11] Study Details - The FENhance studies (1 and 2) involved 1,497 adult patients with RMS, randomized to receive either oral fenebrutinib or teriflunomide for at least 96 weeks [5][6] - The primary endpoint for FENhance studies was the annualised relapse rate (ARR), with key secondary endpoints including various measures of confirmed disability progression [6][9] - The FENtrepid study included 985 adult patients with PPMS, comparing fenebrutinib to OCREVUS over a treatment period of at least 120 weeks [7][8] Mechanism of Action - Fenebrutinib targets B cells and microglia, addressing both acute inflammation and chronic damage associated with multiple sclerosis [4][11] - It is a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, designed for high potency and selectivity, allowing it to penetrate the central nervous system [4][11] Future Outlook - Full data from both Phase III studies will be presented at upcoming medical meetings, with regulatory submissions planned following the results of the second RMS study (FENhance 1), expected in the first half of 2026 [3][8]