Roche Pharmaceutical Development and Sales Overview slide image

Roche Pharmaceutical Development and Sales Overview

Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of AB Indication Phase/study # of patients Design " Primary endpoint Status CT Identifier ■ 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 " 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 Neuroscience
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