Roche has released the results of the Phase II study evaluating the efficacy of fenebrutinib for patients with relapsing multiple sclerosis (MS).
The oral BTK inhibitor was put to the test in the FENopta open-label extension study, which demonstrated that patients given the therapeutic experienced low levels of disease activity during the treatment period, while also having no disability progression.
During the 48 week period, 96% of patients experienced no disease relapses — meaning the annual relapse rate sat at 0.04.
At the end of the trial, 99% of patients had no gadolinium-enhancing (T1-Gd+) lesions, which are common biomarkers of inflammation in patients with multiple sclerosis.
T2 lesions — of which high levels are associated with higher disease burden — were also reduced by 3x in patients compared to baseline.
Fenebrutinib's safety profile was also consistent with prior studies, with adverse events including UTIs, COVID-19 and pharyngitis, though this was limited to under 8% of the population.
There were serious adverse events observed in one patient during the study.
Following this positive result for Roche, the company is running three Phase III trials: FENhance 1 and 2 for relapsing MS, and the FENtrepid trial for patients with primary progressive MS.
Data from these studies is expected to be available at the end of 2025.