Genentech, a unit of Roche Holding AG (RHHBY), on Monday announced that its investigational therapy fenebrutinib met the primary endpoint in the Phase III FENhance 2 study in patients with relapsing multiple sclerosis (RMS).
FENhance 2 is one of two pivotal, similarly designed Phase III studies — FENhance 1 and FENhance 2 — evaluating fenebrutinib versus teriflunomide in adult patients with RMS. According to the company, fenebrutinib significantly reduced the annualized relapse rate (ARR) compared with the approved multiple sclerosis therapy teriflunomide over a treatment period of at least 96 weeks.
In addition, the Phase III FENtrepid study evaluating fenebrutinib versus Ocrevus in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint, demonstrating non-inferiority to ocrelizumab — currently the only approved therapy for PPMS.
"Fenebrutinib substantially reduced the number of relapses in RMS and slowed disability progression in PPMS. These unprecedented results suggest that fenebrutinib could potentially become a best-in-disease medicine as the first high-efficacy, oral treatment for people with RMS or PPMS," said Levi Garraway, Genentech's chief medical officer and head of Global Product Development.
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