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 Prodromal Alzheimer's disease Mild Alzheimer's disease Roche Cognitively unimpaired participants at risk for or at the earliest stages of Alzheimer's disease Phase/study # of patients Design " Primary endpoint Status Phase II/III Scarlet ROAD¹ N=799 104-week SC treatment period: ARM A: Gantenerumab (225 mg) ARM B: Gantenerumab (105 mg) ARM C: Placebo Change in CDR-SOB at 2 years Sub-study: change in brain amyloid by PET at 2 years Phase I PET data: Archives of Neurology, 2012 Feb;69(2):198-207 Recruitment completed Q4 2013 Dosing stopped due to futility Q4 2014 FPI in open label extension study Q4 2015 Published in Alzheimers Res Ther 2017 Dec 8;9(1):95 Phase III Marguerite ROAD¹ N=389 104-week SC treatment period: ARM A: Gantenerumab ARM B: Placebo Change in ADAS-Cog and CDR-SOB at 2 years (co-primary) Phase III SKYLINE² N=1,200 ARM A: Gantenerumab q1w or q2w (patient preference) ARM B: Placebo Cognitive composite (PACC5) • FPI Q1 2014 FPI Q2 2022 Recruitment stopped Q4 2015 " FPI Q1 2016 for open label extension CT Identifier NCT01224106 36 OLE data published in J Prev Alzheimers Dis 2021;8(1):3-6 NCT02051608 NCT05256134 'In collaboration with MorphoSys AG; 2In collaboration with Banner Alzheimer's Institute AB-amyloid-beta; CDR-SOB-Clinical Dementia Rating Scale Sum of Boxes; PET= positron emission tomography; ADAS-cog-Alzheimer's Disease Assessment Scale cognitive subscale; SC=Subcutaneous; OLE=Open Label Extension; PACC5=Preclinical Alzheimer's Cognitive Composite 123 Neuroscience
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