PK/PD modeling framework to inform the clinical development of RG6102, an amyloid-targeting investigational drug with enhanced brain penetration properties

Monoclonal antibodies that remove beta-amyloid have been linked to improved cognition in patients with Alzheimer’s disease. RG6102 is a monoclonal antibody under development that combines the anti-beta-amyloid antibody gantenerumab with a “Brain Shuttle” module that binds to the transferrin receptor 1, facilitating the transport across the blood-brain barrier. This presentation discusses the continued development of a pharmacokinetic/pharmacodynamic translational model, which was used to inform the first-in-human study dose range for RG6102, and subsequently, to guide the selection of dose levels and dosing frequency for patients with Alzheimer’s disease.