Roche’s Alzheimer’s disease therapy has continued to show benefit for patients after 28 weeks in a long-term extension study.
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.
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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).
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By GlobalDataTo 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.”
Roche previously presented data from the Brainshuttle AD trial at Alzheimer’s and Parkinson’s Diseases (AD/PD) 2025, where 81% of evaluable patients in the 3.6mg/kg cohort were below the amyloid positivity threshold of 24 centiloids after 28 weeks.
Alzheimer’s market set to grow
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.
GlobalData is the parent company of Clinical Trials Arena.
This news also comes as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Eli Lilly’s Alzheimer’s disease drug Kisunla (donanemab), but in a limited patient population.
The committee has recommended its approval in patients with early Alzheimer’s symptoms who have one or no copies of the apolipoprotein E ε4 (ApoE4) gene. This is due to this patient population being at lower risk of ARIA, one of the more serious adverse events (AEs) associated with Lilly’s therapy.
Both Eli Lilly’s Kisunla and Eisai’s Leqembi (lecanemab) have faced a difficult time elsewhere in Europe. Both have been rejected for use by the National Institute for Health and Care Excellence, meaning they are unavailable for access through the National Health Service (NHS) in England. Both companies told Pharmaceutical Technology, a sister title to Clinical Trials Arena, that they would be appealing the decision.
Both drugs have been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), meaning they are available privately in the UK.
