Roche's Brainshuttle Shows Promise in Alzheimer's Breakthrough Trial

Roche’s novel Brainshuttle™ technology may usher in a new generation of anti-amyloid monoclonal antibodies (mAbs) for Alzheimer’s treatment, as early trial results from its experimental drug trontinemab show significant promise. The findings were presented at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, highlighting the potential of the drug to overcome the longstanding challenge of limited brain penetration (1^✔ ✔Trusted Source
Roche's Brainshuttle technology promises next generation of amyloid beta mAbs, says GlobalData

Go to source). According to GlobalData, a leading data and analytics company, the interim clinical data validates the Brainshuttle platform’s ability to deliver therapeutic antibodies more effectively across the blood-brain barrier—a critical hurdle in treating neurodegenerative conditions like Alzheimer's disease (AD).

“Trontinemab achieved rapid and robust amyloid plaque reduction at low systemic doses,” said Erela Dana, Director of Neurology at GlobalData.

The study tested multiple intravenous doses—1.8mg/kg and 3.6mg/kg—administered every four weeks in patients with prodromal to moderate AD. Researchers observed rapid and significant reductions in amyloid plaques, with no treatment non-responders at the 28-week follow-up, according to the report.

Complementing these findings, Roche presented biomarker data indicating meaningful neurobiological improvements. A cerebrospinal fluid (CSF) analysis after 25 weeks at the 3.6mg/kg dose revealed:

• 84% increase in Aβ42/40 ratio
• 29% decrease in phosphorylated tau 181 (p-tau181)
• 21% drop in neurogranin
• 22% reduction in total tau

Plasma biomarkers mirrored these improvements, with a 36% reduction in p-tau181 and a 51% reduction in p-tau217 after six months—key indicators of Alzheimer’s progression and response to treatment.

Roche's Trontinemab in Alzheimer's Trial

Roche’s trontinemab also demonstrated a favorable safety profile, especially concerning amyloid-related imaging abnormalities (ARIA), a common and often serious side effect of current Alzheimer’s therapies like Leqembi and Kisunla. Only three mild-to-moderate cases of ARIA-E (edema/effusion) were reported in the lower-dose group (3.9%), all of which resolved within four to eight weeks. Notably, no ARIA-E cases were seen at the higher 3.6mg/kg dose, and no instances of ARIA-H (microhemorrhages or siderosis) occurred.

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Buoyed by the interim results, Roche is set to launch a pivotal Phase III trial for trontinemab later in 2025. If the final data confirms these early outcomes, trontinemab could set a new benchmark in anti-amyloid therapies—delivering faster, deeper amyloid clearance with fewer side effects and lower systemic dosing.

“The Brainshuttle technology could also have broader implications beyond AD,” Dana noted, “potentially enabling more efficient delivery of antibody therapies for other neurological disorders where the blood-brain barrier poses a major therapeutic challenge.”

As the global burden of Alzheimer’s continues to grow, innovations like Brainshuttle and trontinemab may represent a turning point in the development of safer and more effective treatments for neurodegenerative diseases.

Reference:

1. Roche’s Brainshuttle technology promises next generation of amyloid beta mAbs, says GlobalData - (https://www.globaldata.com/media/pharma/roches-brainshuttle-technology-promises-next-generation-of-amyloid-beta-mabs-says-globaldata/)

Source-Medindia