Genentech, associated with Roche, has released promising 96-week data for their experimental drug fenebrutinib. Patients with relapsing multiple sclerosis (MS) experienced stable disability levels and minimal disease activity over the two-year period. These findings from the Phase II FENopta open-label extension study were shared at the Consortium of Multiple Sclerosis Centers Annual Meeting held in Phoenix, Arizona.
Fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, showed an impressive annual relapse rate, averaging one relapse per 17 years, with no noticeable disability progression, assessed by the Expanded Disability Status Scale. MRI results indicated suppressed brain disease activity, with no new T1 gadolinium-enhancing lesions, signaling active inflammation, detected by 96 weeks. Additionally, the presence of new or enlarging T2 lesions decreased significantly for patients transitioning from placebo to fenebrutinib.
Throughout the study, fenebrutinib maintained a consistent safety profile. Common adverse events included COVID-19, urinary and respiratory tract infections, and pharyngitis. Serious adverse events were rare, seen in only two patients. Currently, three Phase III trials are underway, aiming to further evaluate fenebrutinib's impact on MS, with initial results anticipated in late 2025.
