Roche announced new late-breaking data from the phase-III FENtrepid study showing the investigational Bruton’s Tyrosine Kinase (BTK) inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to OCREVUS (ocrelizumab) in reducing disability progression in patients with Primary Progressive Multiple Sclerosis (PPMS). Fenebrutinib showed a 12 percent reduction in the risk of disability progression compared to OCREVUS, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite Confirmed Disability Progression (cCDP12) (hazard ratio [HR] 0.88; 95 percent confidence interval [CI]: 0.75, 1.03) with curves separating as early as 24 weeks. A consistent treatment effect on cCDP12 was observed across patient subgroups and for the entire treatment duration.

“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,” said Professor Amit Bar-Or, Director, Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania.

The cCDP12 primary endpoint included the CDP based on the Expanded Disability Status Scale (EDSS) for functional disability, the timed 25-foot walk (T25FW) for walking speed and the nine-hole peg test (9HPT) for upper limb function. The strongest treatment effect was observed on the risk of worsening on the 9HPT by 26 percent (HR 0.74; 95 percent CI: 0.56, 0.98) compared to OCREVUS.

“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. We look forward to advancing our regulatory submission following the upcoming readout of our second pivotal RMS study, FENhance 1,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche.