Biogen Inc. (Nasdaq: BIIB) today 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. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and address unmet medical needs..

Biogen Inc.（纳斯达克股票代码：BIIB）今天宣布，美国食品药品监督管理局 (FDA) 已授予 BIIB080 快速通道资格。BIIB080 是一种研究性反义寡核苷酸 (ASO) 疗法，靶向 tau 蛋白，用于治疗阿尔茨海默病。快速通道资格旨在促进用于治疗严重疾病和满足未竟医疗需求的在研药物的开发和加快审查进程。

“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,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “Alzheimer’s is a complex and fatal disease that we believe will require multiple therapeutic approaches to address its diverse pathologies.

“我们对BIIB080获得FDA的快速通道资格感到鼓舞，这突显了针对阿尔茨海默病中tau病理的创新治疗的迫切需求，”渤健公司开发主管Priya Singhal博士、公共卫生硕士表示，“阿尔茨海默病是一种复杂且致命的疾病，我们认为需要多种治疗方法来应对它的多样化病理。”

BIIB080, an investigational antisense therapy, is a differentiated approach to targeting tau, with promising potential for patients. We are advancing this program with urgency on behalf of people living with Alzheimer’s and their families.”.

BIIB080 是一种研究性反义疗法，是一种针对 tau 蛋白的独特方法，对患者具有良好的潜力。我们正在加紧推进这一项目，以期帮助阿尔茨海默病患者及其家人。

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. As

BIIB080是首个进入阿尔茨海默病临床开发的靶向tau蛋白的ASO，目前正在早期患者中进行全球二期CELIA研究评估。

previously announced

之前已宣布的

, results from the Phase 1b study 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, supporting the potential for clinical benefit.

，1b期研究结果显示，脑脊液（CSF）中可溶性tau蛋白呈剂量依赖性减少，正电子发射断层扫描（PET）测量的脑内聚集tau病理减少，并且在探索性临床结果中呈现出积极趋势，这支持了其潜在的临床益处。

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 a data readout expected in 2026..

在高剂量组中，观察到在认知和功能的多个探索性指标上有积极的趋势。二期CELIA研究现已全部招募完毕，预计将在2026年进行数据读取。

About BIIB080

关于BIIB080

BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer’s disease and is associated with neurodegeneration and cognitive decline.

BIIB080是一种研究性反义寡核苷酸（ASO）疗法，旨在靶向微管相关蛋白tau（MAPT）mRNA，以减少tau蛋白的产生。Tau在大脑中的异常积累是阿尔茨海默病的标志，并与神经退行性和认知能力下降有关。

BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer’s disease..

BIIB080目前正在进行一项针对早期阿尔茨海默病患者的2期临床研究（NCT05399888）。

In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO).

2019年12月，Biogen行使了与Ionis Pharmaceuticals的许可选择权，并获得了在全球范围内开发和商业化BIIB080（tau ASO）的独家、含特许权使用费的许可。

About Biogen

关于百健公司

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes.

成立于1978年的Biogen是一家领先的生物技术公司，致力于通过开创性科学创新推出新药，以改变患者生活，并为股东和社区创造价值。我们凭借对人类生物学的深刻理解，利用不同模式推动首创性治疗方案或疗法的发展，以实现卓越的治疗效果。

Our approach is to take bold risks, balanced with return on investment to deliver long-term growth..

我们的方法是大胆冒险，同时平衡投资回报，以实现长期增长。