Gantenerumab (Roche/MorphoSys) is a fully humanized centrally and N-acting monoclonal antibody that primarily targets fibrillar amyloid-beta. It acts by preventing amyloid-beta plaque formation, promoting microglia-mediated clearance. This binding and clearance is essential as amyloid-beta accumulation is a hallmark feature of Alzheimer’s disease.
Gantenerumab is currently in Phase III development for the treatment of mild Alzheimer’s disease and for individuals prone to developing Alzheimer’s disease due to the presence of a genetic mutation (Biomedtracker, 2015; Medtrack, 2015). In December 2014, SCarlet RoAD, a Phase III study evaluating gantenerumab in prodromal patients, was discontinued.
Despite gantenerumab’s (Roche/MorphoSys) failure to demonstrate clinical efficacy in prodromal Alzheimer’s disease, a study examining efficacy in patients with mild Alzheimer’s disease (Marguerite RoAD) is ongoing. While Roche remains confident in gantenerumab’s disease-modifying potential, Datamonitor Healthcare’s expectations for the Marguerite RoAD trial are dim unless changes in the dosing regimen can be applied to influence clinical outcomes.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 gantenerumab : Alzheimer’s disease
LIST OF FIGURES
8 Figure 1: Gantenerumab for Alzheimer’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of gantenerumab in Alzheimer’s
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of gantenerumab in Alzheimer’s
LIST OF TABLES
4 Table 1: Gantenerumab drug profile
5 Table 2: Gantenerumab Phase III data in Alzheimer’s disease
6 Table 3: Gantenerumab Phase III trials in Alzheimer’s disease
Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered office is Suite 1, 3rd Floor, 11 - 12 St. James's Square, London, England, SW1Y 4LB. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.