Roche (RHHBY.US) BTK inhibitor MS Phase II results released

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

Fenebrutinib is an oral, reversible, non-covalent BTK inhibitor that blocks BTK function. Preclinical data showed that fenebrutinib has strong activity and high selectivity, with 130-fold selectivity for BTK over other kinases. Fenebrutinib is the only reversible inhibitor in multiple sclerosis Phase III trials.

Levi Garraway, M.D., Roche's chief medical officer and head of global product development, said: "After one year of treatment, our BTK inhibitor fenebrutinib is able to suppress nearly all disease activity and disability progression in patients with multiple sclerosis. If these results are validated in ongoing Phase III studies, fenebrutinib can further advance the treatment landscape for patients with multiple sclerosis."