Swiss pharmaceutical giant, Roche has announced encouraging 48-week data from the Phase II FENopta open-label extension (OLE) study for fenebrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor. The data is to be presented at the upcoming 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen. The results show that fenebrutinib, a drug that targets relapse multiple sclerosis (RMS), could be a big step forward in therapy, possibly slowing the disease's progression and making things better for patients.

The study found that participants treated with fenebrutinib had very low levels of disease activity and no disability progression during a 48-week period. Specifically, 96% of patients were relapse-free after one year, with an annualised relapse rate (ARR) of only 0.04 and no change in disability as determined by the Expanded Disability Status Scale (EDSS). Similar findings were confirmed by MRI scans, with 99% of patients devoid of T1 gadolinium-enhancing (T1-Gd+) lesions, which indicate ongoing inflammation. Notably, the volume of T2 lesions, which indicate chronic disease load, decreased threefold compared to the double-blind period. 

Announcing the results, Dr Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development stated, "After a year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in people with multiple sclerosis." Should the ongoing Phase III trials confirm these findings, fenebrutinib could significantly enhance the therapeutic landscape for individuals with multiple sclerosis.

The study's findings are relevant, considering the unmet need for effective medicines that address both disease activity and disability progression in multiple sclerosis. Fenebrutinib's combined suppression of B-cell and microglial activation may be critical in meeting this demand. Its safety profile is consistent with earlier studies, with the most common adverse events being urinary tract infections, COVID-19, and pharyngitis. 

The company further informed that currently, three Phase III trials are underway to further assess fenebrutinib's efficacy across the multiple sclerosis spectrum, with results expected by the end of 2025. These studies could establish fenebrutinib as an important treatment option for patients with relapsed multiple sclerosis and primary progressive multiple sclerosis (PPMS).