Half-Year 2022 Financial and Clinical Trials Update
Fenebrutinib (RG7845, GCD-0853)
Highly selective and reversible (noncovalent) bruton tyrosine kinase
Indication
Primary progressive multiple sclerosis
(PPMS)
Relapsing multiple sclerosis (RMS)
Phase/study
Phase III
FENtrepid
Phase III
FENhance 1
N=736
# of patients
N=946
ARM A: Fenebrutinib twice daily oral
ARM B: Ocrevus 2x300mg IV q24w
ARM A: Fenebrutinib twice daily oral
ARM B: Teriflunomide once daily oral
Design
Time to onset of CCDP12
Primary endpoint
■ FPI Q4 2020
Status
CT Identifier
NCT04544449
IV-Intravenous; CCDP12-Composite 12-week confirmed disability progression
Time to onset of CCDP12 and annualized
relapse rate
☐
FPI Q1 2021
NCT04586023
Phase III
FENhance 2
N=736
ARM A: Fenebrutinib twice daily oral
ARM B: Teriflunomide once daily oral
Time to onset of CCDP12 and annualized
relapse rate
▪ FPI Q1 2021
NCT04586010
148
Roche
NeuroscienceView entire presentation