The therapeutic armamentarium for the treatment of Relapsing Multiple Sclerosis could soon be enriched with a new treatment. The data from the phase II study FENopta on Roche’s oral BTK inhibitor, fenebrutinib showed “near-complete suppression” of disease activity and disability progression after one year of treatment.
The full results of the FENopta study will be presented on 40 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)which will be held in Copenhagen from 18 to 20 September.
At 48 weeks, the 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation. Furthermore, the available data from the study showed a annualized relapse rate (ARR) of 0.04 e no change in disability measured by the Expanded Disability Status Scale (EDSS). The most common adverse events reported were urinary tract infections, COVID-19 and pharyngitis, with a serious reaction observed in only one patient.
“After one year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in people with multiple sclerosis,” says Levi Garraway, Chief Medical Officer di Roche. “If these results are validated in the ongoing Phase III studies, fenebrutinib could further advance the treatment landscape for people with multiple sclerosis.”
Roche is conducting three late-stage studies: FENhance 1 e 2 in relapsing multiple sclerosis – comparing fenebrutinib with teriflunomide Of Sanofi – e FENtrepidwhich compares it with antibody therapy ocrelizumab of the same German pharma in Primary progressive MS.