Roche Announces Positive Phase II Results for BTK Inhibitor Fenebrutinib in Relapsing Multiple Sclerosis

On September 4, Roche (RHHBY.US) announced the latest results of the Phase II FENopta open-label extension (OLE) study of the BTK inhibitor fenebrutinib. The results showed that patients with relapsing multiple sclerosis (RMS) who received fenebrutinib for up to one year maintained a very low level of disease activity and did not experience disease progression. Roche will present the latest data from the FENopta-OLE study at the 40th meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

It is reported that Fenebrutinib is an oral, reversible, non-covalent BTK inhibitor that can block the function of BTK. Preclinical data show that fenebrutinib has strong activity and high selectivity, with a selectivity for BTK that is 130 times higher than other kinases. Fenebrutinib is currently the only reversible inhibitor in Phase III trials for multiple sclerosis.

Levi Garraway, MD, Chief Medical Officer and Head of Global Product Development at Roche, stated: "After one year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in patients with multiple sclerosis. If these results are validated in the ongoing Phase III studies, fenebrutinib could further advance the treatment landscape for patients with multiple sclerosis."

Editorial Responsibility: Guo Mingyu