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news.Biogen has received fast track designation from the US Food and Drug Administration (FDA) for its investigational antisense oligonucleotide (ASO) therapy, BIIB080, to treat Alzheimer's disease.
BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer's disease. Credit: Steven HWG for Unsplash.
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This status is aimed at facilitating the development and speeding up the review process for drugs that address serious conditions and fill unmet medical needs.
Biogen development head Priya Singhal said: “We are encouraged by the FDA’s fast track designation for BIIB080, which highlights the urgent need for innovative treatments targeting tau pathology in Alzheimer’s disease.”
“Alzheimer’s is a complex and fatal disease that we believe will require multiple therapeutic approaches to address its diverse pathologies. BIIB080, an investigational antisense therapy, is a differentiated approach to targeting tau, with promising potential for patients. We are advancing this programme with urgency on behalf of people living with Alzheimer’s and their families.”
BIIB080 is engineered to target the microtubule-associated protein tau (MAPT) mRNA, with the goal of reducing the tau protein production.
Accumulation of abnormal tau protein in the brain is a key characteristic of Alzheimer’s disease, leading to neurodegeneration and cognitive decline.
BIIB080 is the first tau-targeting ASO to enter clinical development for the disease.
Currently, it is being assessed in the global Phase II CELIA trial, which includes participants with early-stage Alzheimer’s disease.
A Phase Ib study previously revealed dose-dependent reductions in soluble tau protein in cerebrospinal fluid (CSF), decline in brain’s aggregated tau pathology as measured by positron emission tomography (PET), and positive exploratory outcome trends.
These findings support the potential clinical benefit of BIIB080.
In the high-dose cohorts of the study, multiple exploratory measures of cognition and function exhibited “favourable” trends. With the Phase II CELIA study now enrolled completely, the anticipated data readout is set for 2026.
