Roche reports positive 48-week results for BTK inhibitor in relapsing MS

Roche has revealed encouraging new 48-week data for its investigational drug fenebrutinib in individuals with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta open-label extension (OLE) study indicated that adults treated with fenebrutinib for up to a year maintained very low levels of disease activity and showed no progression in disability.

MS is a neurological disorder affecting approximately 2.9 million people globally. It occurs when the immune system attacks the myelin sheath, a protective layer covering the nerves, thereby disrupting communication between the brain and the rest of the body. Fenebrutinib is classified under Bruton’s tyrosine kinase (BTK) inhibitors, which function by selectively inhibiting the cells responsible for the autoimmune response in MS.

Previously, the 12-week FENopta study had achieved its primary and secondary objectives, demonstrating that oral fenebrutinib significantly reduced MRI markers indicative of MS disease activity in the brain compared to a placebo. The new findings from the OLE study further support these results, showing that 96% of patients on fenebrutinib experienced no relapses after one year, with an annualized relapse rate of just 0.04.

The study also found no changes in disability over 48 weeks, as measured by the Expanded Disability Status Scale. Furthermore, 99% of patients were free of T1 gadolinium-enhancing lesions, which are markers of active inflammation, throughout the study period. These comprehensive results are scheduled to be presented later this month at the Congress of the European Committee for Treatment and Research in MS.

In addition to the FENopta study, Roche is conducting three late-stage trials for fenebrutinib. These include the FENhance 1 and 2 trials focused on relapsing MS and the FENtrepid study aimed at primary progressive MS, a form that affects 15% of MS patients.

Roche’s chief medical officer and head of global product development expressed optimism about the findings, stating, "After a year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in people with MS." He added that if these results are confirmed in the ongoing phase 3 trials, fenebrutinib could significantly impact the treatment landscape for MS patients.

Fenebrutinib is noted as the only reversible BTK inhibitor currently in phase 3 development for MS, highlighting its unique position in ongoing research. Roche's announcement comes on the heels of another promising BTK inhibitor study from Sanofi. Sanofi's drug, tolebrutinib, also showed positive results in a phase 3 trial involving patients with non-relapsing secondary progressive MS.

Overall, these findings suggest that fenebrutinib could offer substantial benefits for those living with relapsing forms of MS, pending further validation from the ongoing phase 3 studies. With its ability to reduce disease activity and halt disability progression, fenebrutinib represents a potential new advancement in the treatment of MS.

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