Roche's fenebrutinib demonstrated near-complete suppression of disease activity and disability progression for up to 48 weeks in patients with relapsing multiple sclerosis

Core Insights - Roche's investigational BTK inhibitor fenebrutinib shows promising results in treating relapsing multiple sclerosis (RMS), with 96% of patients free from relapses after one year and an annualized relapse rate (ARR) of 0.04 [2][3] - The Phase II FENopta study data indicates that fenebrutinib effectively suppresses disease activity, with 99% of patients free from T1 gadolinium-enhancing lesions after 48 weeks [3][4] - The ongoing Phase III trials aim to further validate fenebrutinib's efficacy and safety across multiple sclerosis types, with results expected by the end of 2025 [5][7] Company Overview - Roche is focused on developing fenebrutinib as a dual inhibitor targeting both B-cell and microglia activation, addressing unmet medical needs in multiple sclerosis [6][7] - The company has treated over 2,700 patients and healthy volunteers with fenebrutinib across various clinical programs, emphasizing its commitment to neuroscience research [7][15] - Roche's ongoing research includes multiple sclerosis and other neurological disorders, aiming to improve treatment outcomes and patient quality of life [14][15] Clinical Study Details - The FENopta study was a global Phase II trial involving 109 adults with RMS, assessing the efficacy, safety, and pharmacokinetics of fenebrutinib [8][9] - Patients who completed the FENopta study were given the option to participate in an open-label extension study, with 96 patients remaining after one year [10] - The study demonstrated that fenebrutinib crosses the blood-brain barrier and significantly reduces new lesions compared to placebo [9][10]