Roche’s Alzheimer’s therapy shows continued benefit
Roche announced new data from the Phase Ib/IIa Brainshuttle study at AAIC 2025. Roche’s Alzheimer’s disease therapy has continued to show benefit for patients after 28 weeks in a long-term extension study. Roche’s therapy will be investigated in two Phase III studies due to begin by the end of 2025.
In the high-dose cohort from the ongoing Phase Ib/IIa Brainshuttle AD study (NCT04639050), trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in 91% of patients after 28 weeks of treatment, with 72% achieving deep clearance below 11 centiloids.
The trial also saw early and significant reductions in fluid biomarkers of Alzheimer’s disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in CSF and plasma.
The treatment remained safe and tolerable, with amyloid-related imaging abnormalities-oedema/effusion (ARIA-E) being observed in less than 5% of patients. All ARIA-E cases were radiographically mild, with one case associated with mild and transient symptoms.
Roche shared the data in a 90-minute Featured Research session at the Alzheimer’s Association International Conference (AAIC), taking place from 27-30 July in Toronto, Canada, as it gears up to initiate two Phase III studies of the therapy later in 2025.
TRONTIER 1 and 2 will investigate the efficacy and safety of investigational trontinemab in people with early Alzheimer’s disease. The primary endpoint will measure the change in cognition and function based on the Clinical Dementia Rating – Sum of Boxes scale after 18 months of treatment. Secondary endpoints will include assessments of cognition, function, behavioural symptoms, and quality of life (QoL).
To pre-screen for the TRONTIER studies, Roche will be using its fully automated Elecsys pTau217 assay.
Roche’s CMO Dr Levi Garraway said: “Trontinemab is designed to target a key driver of Alzheimer’s disease biology more effectively in the brain. Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention. With plans for Phase III trials in both early symptomatic and preclinical Alzheimer’s disease, we are advancing science with the goal of delaying —and ultimately preventing—progression of this devastating condition.”
GlobalData projects the Alzheimer’s market to rise to $19.3bn in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan and China) in 2033, with trontinemab, if approved, set to reach sales of $712m in 2031.
