Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, an investigational antibody targeting the microtubule binding region of tau (MTBR-tau).

百时美施贵宝公司宣布，美国食品药品监督管理局 (FDA) 已授予 BMS-986446 快速通道资格，这是一种针对 tau 蛋白微管结合区 (MTBR-tau) 的研究性抗体。

Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder characterised by memory loss, behavioural changes and cognitive decline. A major feature of the disease is the abnormal build-up and spread of tau proteins in the brain. MTBR-tau fragments are thought to play a central role in the development of neurofibrillary tangles, which contribute to nerve cell death..

阿尔茨海默病是最常见的痴呆类型，是一种以记忆丧失、行为改变和认知衰退为特征的进行性神经退行性疾病。该疾病的一个主要特征是大脑中tau蛋白的异常积聚和扩散。MTBR-tau片段被认为在神经原纤维缠结的形成中起核心作用，这些缠结导致神经细胞死亡。

BMS-986446 is a humanised monoclonal antibody designed to block tau spread, prevent cellular uptake and stimulate microglia, the brain’s immune cells, to clear tau deposits. By targeting tau pathology, the therapy aims to slow or delay disease progression.

BMS-986446是一种人源化单克隆抗体，旨在阻断tau蛋白扩散、防止细胞摄取并刺激大脑免疫细胞小胶质细胞清除tau蛋白沉积。通过靶向tau蛋白病理，该疗法旨在减缓或延缓疾病进展。

The therapy is currently in Phase 2 development for the treatment of early Alzheimer’s disease.

该疗法目前正处于治疗早期阿尔茨海默病的第二阶段开发中。

Fast Track Designation is intended to accelerate the development and review of medicines that address serious conditions with limited treatment options.

快速通道指定旨在加速开发和审查针对严重疾病且治疗选择有限的药物。

Preclinical studies showed that BMS-986446 reduced tau spread, protected against behavioural decline and localised with tau pathology in Alzheimer’s brain tissue. A Phase 1 trial confirmed the treatment was safe and well tolerated in healthy volunteers.

临床前研究表明，BMS-986446减少了tau蛋白的扩散，防止了行为退化，并在阿尔茨海默病脑组织中与tau病理定位一致。1期试验确认该治疗在健康志愿者中安全且耐受性良好。

The fully enrolled Phase 2 TargetTau-1 trial is now evaluating multiple doses of BMS-986446 in patients with early Alzheimer’s disease, measuring both clinical outcomes and biomarkers of tau and amyloid-beta biology to assess its potential to modify disease progression.

全面入组的二期TargetTau-1试验目前正在评估BMS-986446在早期阿尔茨海默病患者中的多种剂量，测量临床结果以及tau蛋白和β淀粉样蛋白生物标志物，以评估其改变疾病进程的潜力。

Source: bms.com

来源：bms.com