Roche has shared new data from its Alzheimer’s disease (AD) development portfolio at this year’s Alzheimer’s Association International Conference (AAIC), including clinical results for its investigational amyloid-beta targeting monoclonal antibody trontinemab.
In the ongoing phase 1b/2a Brainshuttle AD study, trontinemab was associated with a “rapid and robust” clearance of amyloid plaques, a hallmark of the neurodegenerative disease, with 91% of patients in the 3.6mg/kg dosing cohort becoming amyloid positron emission tomography (PET) negative after 28 weeks of treatment.
The company also shared the design of the late-stage TRONTIER 1 and 2 studies of trontinemab in early symptomatic AD.
The primary endpoint of both trials, which are expected to be initiated later this year, will measure the change in cognition and function after 18 months of treatment, with secondary endpoints including assessments of behavioural symptoms and quality of life.
Another phase 3 study of the drug in preclinical AD is also planned, with the aim of potentially delaying or preventing the progression of the disease to symptomatic stages.
Roche’s chief medical officer and head of global product development, Levi Garraway, said: “Trontinemab is designed to target a key driver of AD biology more effectively in the brain… With plans for phase 3 trials in both early symptomatic and preclinical AD, we are advancing science with the goal of delaying – and ultimately preventing – progression of this devastating condition.”
Beyond trontinemab, Roche shared real-world data supporting the use of Elecsys as a standalone blood test, offering comparable to PET scans and cerebrospinal fluid diagnostics for rule-in and rule-out identification of amyloid pathology.
The test, which has been developed in collaboration with Eli Lilly and Company, received Breakthrough Device Designation from the US Food and Drug Administration last year and will be used in the TRONTIER studies.
Chief executive officer of Roche Diagnostics, Matt Sause, said: “Our data show that the Elecsys pTau217 test performs comparably to PET scans but can be performed with a simple blood draw and analysed in a routine clinical laboratory.
“This has the potential to transform the diagnosis of Alzheimer’s and provide clear answers to caregivers, patients and their families.”