Biogen Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to BIIB080, its investigational antisense oligonucleotide therapy targeting tau for Alzheimer’s disease. This designation is intended to accelerate the development and review of therapies for serious conditions with unmet medical needs.

Priya Singhal, M.D., M.P.H., Head of Development at Biogen, stated that the FDA’s Fast Track status underscores the urgent need for novel treatments addressing tau pathology in Alzheimer’s. She noted that Alzheimer’s is a complex, fatal disease likely requiring multiple therapeutic strategies, and described BIIB080 as a differentiated approach with promising potential. Biogen is advancing the program with urgency on behalf of patients and their families.

BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s and is under evaluation in the global Phase 2 CELIA study in early-stage patients. In the Phase 1b study, BIIB080 produced dose-dependent reductions in soluble tau in cerebrospinal fluid, decreased aggregated tau pathology on PET imaging, and showed favorable trends in exploratory clinical outcomes. High-dose cohorts exhibited positive trends across multiple measures of cognition and function. The Phase 2 CELIA trial is now fully enrolled, with data anticipated in 2026.

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