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Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

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  • Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks.
  • OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no new T1-Gd+ lesions on MRI; pts who switched to fenebrutinib observed reduced annualized rate of new or enlarging T2 lesions from 6.72 at 12wks. to 0.34 by 96wks. Data was shared at CMSC 2025
  • Fenebrutinib is being assessed in 3 ongoing P-III trials incl. FENhance 1 & 2 for RMS as well as FENtrepid for primary progressive multiple sclerosis, with initial data supporting its potential in MS spectrum expected in 2025 end

Ref:  Businesswire| Image:  Genentech| Press Release

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