Roche reports long-term capabilities of multiple sclerosis drug
Posted: 30 May 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The BTK inhibitor enabled near-complete suppression of disability progression for up to two years in individuals with relapsing multiple sclerosis (RMS), the new findings reveal.
New, 96-week trial data show that relapsing multiple sclerosis (RMS) patients given Roche’s Bruton’s tyrosine kinase (BTK) inhibitor maintained low levels of disease activity for up to two years.
These results are from the Phase II FENopta open-label extension (OLE) study of oral fenebrutinib. The drug dually inhibits of both B-cell and microglia activation, which, according to Roche, may reduce both disease activity and disability progression.
Key findings from Roche’s multiple sclerosis trial
The 93 participants who remained in the extension study up to 96 weeks experienced a low annualised relapse rate (ARR) of 0.06, according to the data.
[This new data from the Phase II FENopta open-label extension (OLE) study] show that patients treated with fenebrutinib experienced an annualised relapse rate equal to one relapse every 17 years and no observed disability progression up to two years’’
Findings from the 12-week FENopta study in relapsing multiple sclerosis showed that fenebrutinib crossed the blood-brain barrier. It also significantly reduced new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, compared to placebo. Zero new T1 lesions were detected at the end of the 96-week extension study.
“These data show that patients treated with fenebrutinib experienced an annualised relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,” stated Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
“Fenebrutinib is potent, highly selective and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year,” added Dr Garraway.
These new findings suggest Roche’s BTK inhibitor has potential to broaden the treatment landscape for the disease. Notably, there was no US Food and Drug Administration (FDA)-approved treatments for primary progressive multiple sclerosis (PPMS) until the agency approved Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq) in September 2024, Roche explained.
The new data from the FENopta trial were presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
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