Roche has announced positive new 48-week data for investigational fenebrutinib in patients with relapsing forms of multiple sclerosis (MS).
The phase 2 FENopta open-label extension (OLE) study demonstrated that adults treated with the drug for up to one year maintained very low levels of disease activity and no disability progression.
Affecting approximately 2.9 million people worldwide, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
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 12-week FENopta study previously met its primary and secondary endpoints, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo.
Now, new data from the OLE has shown that 96% of patients receiving the candidate were free of relapses at one year, with an annualised relapse rate of 0.04.
Additionally, there were no changes in disability at 48 weeks, as measured by the Expanded Disability Status Scale, and 99% of patients were free of T1 gadolinium-enhancing lesions, markers of active inflammation, over the same time period.
The full results are set to be presented later this month at the Congress of the European Committee for Treatment and Research in MS.
Three late-stage trials of the drug are ongoing, including the FENhance 1 and 2 trials in relapsing MS and the FENtrepid study in primary progressive MS, which affects 15% of patients.
Roche’s chief medical officer and head of global product development, said: “After a year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in people with MS.
“If these results are validated in the ongoing phase 3 trials, fenebrutinib could further advance the treatment landscape for people living with MS.’’
Fenebrutinib is the only reversible inhibitor currently in phase 3 development for MS, according to Roche.
The company’s announcement comes just days after Sanofi’s own investigational BTK inhibitor tolebrutinib demonstrated promising results in a phase 3 study of patients with non-relapsing secondary progressive MS.