Roche Pharmaceutical Development and Sales Overview
Fenebrutinib (RG7845, GCD-0853)
Highly selective and reversible (noncovalent) bruton tyrosine kinase
Indication
Primary progressive multiple sclerosis
(PPMS)
Relapsing multiple sclerosis (RMS)
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase III
FENtrepid
Phase III
FENhance 1
Phase III
FENhance 2
N=946
N=736
N=736
■
ARM A: Fenebrutinib twice daily oral
■
☐
ARM B: Ocrevus 2x300mg IV q24w
ARM A: Fenebrutinib twice daily oral
ARM B: Teriflunomide once daily oral
■
ARM A: Fenebrutinib twice daily oral
ARM B: Teriflunomide once daily oral
"
Time to onset of CCDP12
Time to onset of CCDP12 and annualized
relapse rate
FPI Q4 2020
FPI Q1 2021
NCT04544449
IV-Intravenous; CCDP12-Composite 12-week confirmed disability progression
NCT04586023
Time to onset of CCDP12 and annualized
relapse rate
FPI Q1 2021
NCT04586010
126
Roche
NeuroscienceView entire presentation