Fenebrutinib Shows Promising Results in Relapsing Multiple Sclerosis Treatment

Fenebrutinib Efficacy:
Fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor developed by Roche, has shown significant suppression of disease activity and disability progression in patients with relapsing multiple sclerosis (MS).

Clinical Trial Results:
In the Phase II FENopta study, 96% of patients treated with fenebrutinib were free of relapses at one year, with an annualized relapse rate (ARR) of 0.04. Additionally, 99% of patients were free of T1 gadolinium-enhancing lesions, indicating minimal active inflammation.

Safety Profile:
The safety profile of fenebrutinib was consistent with previous reports, with urinary tract infection, COVID-19, and pharyngitis being the most common adverse events. One serious adverse event of asymptomatic aminotransferase elevation was resolved with treatment discontinuation.

Ongoing Trials:
Phase III trials, including FENhance 1, FENhance 2, and FENtrepid, are ongoing to further evaluate fenebrutinib in relapsing MS and primary progressive MS. Results are expected by the end of 2025.

Partial Clinical Hold:
The FDA placed a partial clinical hold on fenebrutinib’s MS program in December 2023 due to cases of liver injury. This hold affects new enrollment in Phase III studies in the US but does not impact enrollment in other countries.