Roche Reports Fenebrutinib Meets Primary Endpoint in Phase III PPMS Trial

Reuters02-08 04:40

Roche Reports Fenebrutinib Meets Primary Endpoint in Phase III PPMS Trial

Roche Holding AG has announced new late-breaking data from the Phase III FENtrepid study evaluating fenebrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, in patients with primary progressive multiple sclerosis (PPMS). The results, presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026 in San Diego, showed that fenebrutinib met its primary endpoint of non-inferiority compared to OCREVUS (ocrelizumab), the current standard of care, in reducing disability progression. Fenebrutinib demonstrated a 12% reduction in the risk of disability progression compared to OCREVUS as measured by time to onset of 12-week composite confirmed disability progression (cCDP12). Additional analysis indicated a potential benefit in upper limb function. Regulatory submission for fenebrutinib in both PPMS and relapsing multiple sclerosis (RMS) is planned following the readout of the second pivotal RMS study, FENhance 1, which is expected in the first half of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001163481-en) on February 07, 2026, and is solely responsible for the information contained therein.

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