Roche recently announced the latest progress of its AD pipeline at the Alzheimer's Disease (AD) International Conference (AAIC), including the latest positive data of its investigational antibody trontinemab in the phase 1b/2a Brainshuttle AD study. The study data showed,Trontinemab consistently achieves rapid and significant amyloid plaque clearance.

The latest results published this time are from the second part (dose expansion phase) of the Brainshuttle AD study, which investigated trontinemab for the treatment of Alzheimer's disease patients. The analysis shows that trontinemab continues to demonstrate rapid and significant amyloid plaque clearance effects.Among them, 91% of the subjects turned negative in the amyloid positron emission tomography (PET) assessment, and the incidence of amyloid-related imaging abnormalities (ARIA-E) associated with edema/effusion remained below 5%.

Roche also announced the trial designs of TRONTIER 1 and TRONTIER 2 Phase 3 clinical studies, which will evaluate the efficacy of trontinemab in early symptomatic Alzheimer’s disease. The trial is expected to commence later this year. Additionally, Roche plans to initiate a new Phase 3 clinical trial to assess the therapeutic potential of trontinemab in preclinical Alzheimer’s disease patients, targeting populations at higher risk of cognitive decline.

▲Introduction to Trontinemab(Image source: Reference [2])）

Trontinemab is a monoclonal antibody targeting amyloid proteins that utilizes Roche's Brain Shuttle technology.This drug fuses a monoclonal antibody targeting amyloid proteins with a protein domain that binds to the transferrin receptor, thereby assisting it in crossing the blood-brain barrier. It can rapidly and effectively clear amyloid deposits in the brain 3-6 months after administration.

References:

[1] Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceutical portfolios at AAIC. Retrieved July 28, 2025 from https://www.roche.com/media/releases/med-cor-2025-07-28

[2] LATEST INTERIM RESULTS FROM THE BRAINSHUTTLE™ AD STUDY, A PHASE IB/IIA STUDY OF TRONTINEMAB IN PEOPLE WITH ALZHEIMER’S DISEASE. Retrieved October 30, 2024 from https://medically.roche.com/global/en/neuroscience/ctad-2024/medical-material/CTAD-2024-presentation-kulic-latest-interim-results-from-brainshuttle-ad-study-pdf.html