Roche has shared positive new 96-week data for its investigational fenebrutinib in patients with relapsing forms of multiple sclerosis (MS).
Results from the phase 2 FENopta open-label extension (OLE) study, presented at this year’s Consortium of Multiple Sclerosis Centers annual meeting, showed that patients treated with fenebrutinib maintained no disability progression and low levels of disease activity for up to two years.
Affecting more than 2.9 million people worldwide, MS is a chronic immune-mediated disease of the central nervous system that disrupts communication between the brain and the rest of the body.
Relapsing MS, characterised by attacks of worsening neurologic function followed by partial or complete recovery periods, is the most common form, accounting for around 85% of initial diagnoses.
Taken orally, fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which work by selectively blocking the cells that drive the autoimmune reaction behind MS.
The latest results from FENopta demonstrated that patients treated with the candidate for up to 96 weeks had a low annualised relapse rate of 0.06 and, during this time, there was no disability progression, as measured by the Expanded Disability Status Scale.
Roche’s drug was shown in MRI scans to suppress disease activity in the brain, with no new T1 gadolinium-enhancing lesions detected at 96 weeks.
Additionally, among patients who switched from placebo to fenebrutinib in the OLE, the annualised rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12 week double-blind period to 0.34 by 96 weeks.
The safety profile of fenebrutinib was also found to be consistent with previously reported data, Roche outlined, with no new safety concerns identified at 96 weeks.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “This data shows 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.”
Garraway added that the drug is currently in phase 3 clinical trials for MS and the company is “[looking] forward to seeing the first of those results later this year”.