Roche Pharmaceutical Development and Sales Overview
Gantenerumab (RG1450)
Fully human monoclonal antibody binding aggregated forms of AB
Indication
Phase/study
# of patients
Design
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Primary endpoint
Status
CT Identifier
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Phase III
GRADUATE 1
N=1,016
Prodromal to mild Alzheimer's disease
Phase III
GRADUATE 2
N=1,016
104-week SC treatment period:
ARM A: Gantenerumab
ARM B: Placebo
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104-week SC treatment period:
ARM A: Gantenerumab
ARM B: Placebo
Phase II
GRADUATION
N=192
104-week SC treatment period:
Gantenerumab SC treatment q1w dosing
regimen
Roche
Change in CDR-SOB at 27 months
FPI Q2 2018
Recruitment completed Q2 2020
Change in CDR-SOB at 27 months
FPI Q3 2018
Recruitment completed Q2 2020
BTD granted by FDA Sep 2021
Change from baseline in deposited amyloid (PET
centiloid levels)
FPI Q4 2020
Recruitment completed Q3 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
122
NeuroscienceView entire presentation