Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab

Roche presented new data at the July 2025 Alzheimer’s Association International Conference (AAIC), highlighting progress across both diagnostics and pharmaceuticals for Alzheimer’s disease1.

Trontinemab, Roche’s investigational anti-amyloid antibody using Brainshuttle™ technology, demonstrated rapid and robust reduction of brain amyloid plaques in Phase Ib/IIa studies, with 91% of high-dose patients reaching amyloid clearance below positivity threshold after 28 weeks and 72% achieving deep clearance3.

Trontinemab also led to early and significant reductions in Alzheimer’s disease fluid biomarkers, such as total tau, pTau181, pTau217, and neurogranin, in both CSF and plasma3.

The safety profile was favorable, with mild amyloid-related imaging abnormalities observed in less than 5% of participants and only one instance of mild, short-lived symptoms3.

Roche announced two upcoming Phase III trials (TRONTIER 1 and 2) to start by the end of 2025 for early symptomatic Alzheimer’s, and an additional Phase III trial in people at risk (preclinical stage) to assess prevention of symptomatic disease15.

The company is focusing on earlier and more effective interventions, with the aim of not just treating but potentially preventing progression to symptomatic Alzheimer’s15.

Trontinemab is part of Roche’s renewed commitment to the amyloid hypothesis, following past disappointments with other drugs, and enters a competitive field alongside drugs from Biogen and Lilly2.

Sources:

1. https://www.roche.com/media/releases/med-cor-2025-07-28

2. https://www.biopharmadive.com/news/roche-alzheimers-brain-shuttle-trontinemab/709917/

3. https://www.clinicaltrialsarena.com/news/roche-alzheimers-phase-iii-advance/

5. https://www.bloomberg.com/news/articles/2025-07-27/roche-to-test-whether-new-drug-can-prevent-alzheimer-s-disease