Half-Year 2022 Financial and Clinical Trials Update
Gantenerumab (RG1450)
Fully human monoclonal antibody binding aggregated forms of AB
Indication
Prodromal to mild Alzheimer's disease
Phase/study
# of patients
Phase III
GRADUATE 1
N=1,016
104-week SC treatment period:
ARM A: Gantenerumab
Design
☐
ARM B: Placebo
Phase III
GRADUATE 2
N=1,016
104-week SC treatment period:
ARM A: Gantenerumab
ARM B: Placebo
■ Change in CDR-SOB at 27 months
Primary endpoint
Status
CT Identifier
▪ Change in CDR-SOB at 27 months
FPI Q3 2018
Phase II
GRADUATION
N=192
104-week SC treatment period:
gantenerumab SC treatment q1w dosing regimen
Change from baseline in deposited amyloid (PET
centiloid levels)
▪ Recruitment completed Q3 2021
FPI Q2 2018
☐
■ FPI Q4 2020
Recruitment completed Q2 2020
▪ Recruitment completed Q2 2020
BTD granted by FDA Sep 2021
NCT03443973
NCT03444870
In collaboration with MorphoSys AG
AB-amyloid-beta; CDR-SOB-Clinical Dementia Rating Scale Sum of Boxes; SC-Subcutaneous; BTD=Breakthrough Therapy Designation; PET= positron emission tomography
NCT04592341
Roche
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