New phase III data presented at ACRIMS suggests the oral BTK inhibitor could become a first-in-class multiple sclerosis therapy.
Fenebrutinib has shown first-in-class potential in new phase III findings presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026 meeting.
The oral Bruton’s tyrosine kinase (BTK) inhibitor developed by Genentech, a division of Roche, is the first investigational medicine in over ten years to reduce disability progression in primary progressive multiple sclerosis (PPMS).
Dr Levi Garraway, Ph,D, Chief Medical Officer and Head of Global Product Development, Roche, said: “Fenebrutinib represents the first potential scientific breakthrough for the PPMS community in over a decade, demonstrating a meaningful clinical benefit in reducing disability progression in a study versus the only approved treatment in PPMS.”
Fenebrutinib reduced the risk of disability progression by 12 percent compared to Ocrevus (ocrelizumab) as early as 24 weeks of the phase III FENtrepid study. This met the study’s primary endpoint of non-inferiority compared to Genentech’s own Ocrevus (ocrelizumab), currently the only approved medicine for PPMS.
Notably, fenebrutinib’s unique covalent design facilitates a temporary bond to the target enzyme, helping to limit off-target effects.
Professor Amit Bar-Or, Director of the Center for Neuroinflammation and Neurotherapeutics, University of Pennsylvania, said: “Fenebrutinib showed a consistent clinical benefit as early as week 24, notably in upper limb function, which is essential for preserving independence and daily functioning.
“With only one disease-modifying therapy available for people with PPMS, fenebrutinib has the potential to be a high-efficacy, oral treatment option that acts directly in the brain, targeting progressive biology and may slow disability.”
With only one disease-modifying therapy available for people with PPMS, fenebrutinib has the potential to be a high-efficacy, oral treatment option that acts directly in the brain, targeting progressive biology and may slow disability"
Roche has a second pivotal RMS study of fenebrutinib, the FENhance 1 study, for which data readouts are expected in the first half of 2026, after which the pharma company plans to make regulatory submission for its candidate in both PPMS and RMS.
These data findings follow Genentech in January sharing promising new phase II data for its investigational GLP-1 therapy CT-388.
The firm last week announced signing of a $1.5 billion deal with SanegeneBio for its RNAi pipeline, supporting development of RNA therapies.
