By Fineline Cube 
US-based Biogen Inc. (NASDAQ: BIIB) announced that it has received Fast Track designation (FTD) from the US Food and Drug Administration (FDA) for BIIB080, its tau-targeted antisense oligonucleotide (ASO) therapy for Alzheimer’s disease (AD). This designation underscores the potential of BIIB080 to address the significant unmet medical need in AD treatment.
Collaboration and Licensing
Biogen secured an exclusive, royalty-bearing license to develop and commercialize BIIB080 worldwide through a license option agreement with Ionis Pharmaceuticals in 2019. This strategic partnership has enabled Biogen to advance the development of this innovative therapy.
Clinical Development
BIIB080 is currently under investigation in the global Phase II CELIA study, focusing on patients with early-stage Alzheimer’s disease. The therapy is designed to target microtubule-associated protein tau (MAPT) mRNA, reducing the production of tau protein, which is implicated in the pathogenesis of AD. Key data from this study are anticipated next year, potentially providing further insights into the efficacy and safety of BIIB080.-Fineline Info & Tech