Roche’s meets endpoints in relapsing multiple sclerosis

In patients with relapsing-remitting multiple sclerosis (RRMS), fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to placebo, the primary endpoint. T1 lesions, as measured by MRI, are a marker of active inflammation and T2 lesions represent the amount of disease burden or lesion load. Additionally, the oral drug candidate significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Roche is set to enrol RRMS patients in a pivotal Phase III study.

 “Fenebrutinib inhibits both B cells and microglia and thus has the potential to both reduce MS disease activity, and also impact disease progression, said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

There were no new safety concerns identified in the FENopta study.

Fenebrutinib blocks the function of BTK, an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases.