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Roche Holdings AG (OTC:RHHBY) on Thursday presented new data at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases.
Highlights included presentations from the ongoing trontinemab Phase 1b/2a Brainshuttle AD study, which demonstrated dose-dependent rapid amyloid depletion from the brain and the potential of the Elecsys pTau181 plasma test to rule out amyloid pathology.
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Preliminary results for trontinemab from 114 participants in the 1.8 or 3.6 mg/kg suggest a rapid and deep, dose-dependent reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET).
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Amyloid plaques are extracellular deposits of aggregated amyloid beta peptides (Aβ) that are a hallmark of Alzheimer’s disease, disrupting brain function and contributing to cognitive decline.
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Trontinemab reduced amyloid levels below the 24 centiloid threshold in 81% of participants (n=21/26) in the 3.6 mg/kg dose group after 28 weeks.
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These data were reinforced by early and significant reductions in fluid biomarkers of Alzheimer’s disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in cerebrospinal fluid and plasma.
Trontinemab continues to show a favorable safety and tolerability profile. Amyloid-related imaging abnormalities-edema/effusion (ARIA-E) were observed in <5% (n=3/114) of participants (blinded data), which were radiographically mild, and there was one case associated with mild symptoms.
Trontinemab is currently being studied in the Phase Ib/IIa Brainshuttle AD study assessing the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of trontinemab in participants with Alzheimer’s disease.
Roche also announced that it would initiate a Phase 3 program for trontinemab, which is expected later this year.
Results from 604 participants in a multicentre study of Roche’s Elecsys pTau181 plasma test were presented, demonstrating its potential to accurately rule out amyloid pathology, a hallmark of Alzheimer’s disease, in people with cognitive impairment.
Roche anticipates tests being available in Europe by late 2025, with the U.S. following.
Price Action: RHHBY stock closed lower by 4.37% to $37.65 on Friday.
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