Roche’s fenebrutinib highlights positive phase III results as the only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

Roche has recently announced that the first Phase III of two pivotal, similarly-designed Phase III studies in patients with relapsing multiple sclerosis met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase inhibitor, significantly reduced the annualised relapse rate compared to teriflunomide over a period of at least 96 weeks of treatment.

The Phase III FENtrepid pivotal study evaluating fenebrutinib, compared with OCREVUS in patients with primary progressive multiple sclerosis, met its primary endpoint. The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment.

“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, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Therefore, these pivotal results for fenebrutinib may offer new hope for people living with MS, and they reaffirm our enduring commitment to the MS community.”

Note that Fenebrutinib targets cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. Fenebrutinib, a non-covalent BTKi, is designed to have high potency, selectivity and reversibility. This design allows it to act throughout the body, and also to cross the blood-brain barrier into the central nervous system targeting chronic inflammation.

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Related Topics and Keywords

BTK Inhibitor, multiple sclerosis, Phase III results, primary progressive multiple sclerosis, Roche, Roche’s fenebrutinib