Roche to showcase positive phase II FENopta OLE study data of BTK inhibitor, fenebrutinib for treating relapsing MS at 40th Congress of ECTRIMS

Roche will present new 48-week data from the phase II FENopta open-label extension (OLE) study of fenebrutinib at the ECTRIMS Congress in Copenhagen on September 18, 2024. The data show that patients with relapsing multiple sclerosis (RMS) maintained low disease activity and no disability progression after a second year of fenebrutinib treatment.

In the OLE, 96% of patients were relapse-free with an annualized relapse rate (ARR) of 0.04 and no change in disability as per the Expanded Disability Status Scale (EDSS). MRI results revealed 99% of patients were free of active inflammation lesions, and there was a notable reduction in chronic lesions. The safety profile was consistent with earlier findings, with common adverse events including urinary tract infection and COVID-19.

Fenebrutinib is a reversible BTK inhibitor currently in phase III trials for RMS and primary progressive multiple sclerosis (PPMS). Roche aims to submit regulatory applications in 2026, pending phase III results.