Therapy Areas: Inflammatory Diseases
Genentech reports sustained two-year benefits from fenebrutinib in relapsing multiple sclerosis
30 May 2025 -

Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), on Friday reported 96-week data showing that fenebrutinib sustained near-complete suppression of disease activity and disability progression in patients with relapsing multiple sclerosis.

The Phase II FENopta open-label extension study reported an annualised relapse rate of 0.06 -- equivalent to one relapse every 17 years -- with no observed disability progression, based on the Expanded Disability Status Scale.

MRI results showed no new T1 gadolinium-enhancing lesions after 96 weeks, indicating suppression of active brain inflammation. Patients switching from placebo to fenebrutinib saw a reduction in the annualised rate of new or enlarging T2 lesions from 6.72 to 0.34.

Of the 99 patients who entered the extension, 93 remained on treatment at week 96. The safety profile remained consistent, with no new concerns; the most common adverse events were COVID-19 and urinary tract infections, each at 10%.

Fenebrutinib is a potent, selective and reversible Bruton's tyrosine kinase inhibitor, currently the only one of its kind in Phase III trials for multiple sclerosis.

Genentech expects data from its ongoing Phase III trials -- FENhance 1 and 2 for relapsing MS and FENtrepid for primary progressive MS -- by the end of 2025.

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