Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. The Fast Track designation is intended to facilitate the development and accelerate the review of investigational drugs that address serious conditions and unmet medical needs.

Priya Singhal, M.D., M.P.H., Head of Development at Biogen, expressed encouragement regarding the FDA’s decision, noting that it underscores the urgent need for innovative treatments targeting tau pathology in Alzheimer’s disease. Dr. Singhal emphasized that Alzheimer’s is a complex and fatal disease that likely requires multiple therapeutic approaches to address its diverse pathologies. She highlighted that BIIB080, an investigational antisense therapy, offers a differentiated approach to targeting tau with promising potential for patients. Biogen is advancing the program with urgency for the benefit of individuals living with Alzheimer’s and their families.

BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s disease and is currently being evaluated in the global Phase 2 CELIA study in individuals with early-stage disease. Results from the Phase 1b study, as previously announced, showed dose-dependent reductions in soluble tau protein in cerebrospinal fluid (CSF), decreases in aggregated tau pathology in the brain as measured by positron emission tomography (PET), and favorable trends in exploratory clinical outcomes, suggesting potential clinical benefit. In the high-dose groups, favorable trends were observed across multiple exploratory measures of cognition and function. The Phase 2 CELIA study is now fully enrolled, with data expected in 2026.

Source: https://investors.biogen.com/news-releases/news-release-details/biogens-investigational-tau-targeting-therapy-biib080-receives