Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a monoclonal antibody (mAb) designed to target phosphorylated tau, for the treatment of early Alzheimer’s Disease (AD). Posdinemab is currently under evaluation in the Phase 2b “AuTonomy” clinical trial. Discovered in-house, the antibody has demonstrated the ability to target disease-associated phosphorylated tau in cerebrospinal fluid from patients receiving treatment and to inhibit the formation and spread of tau aggregates in preclinical disease models.

强生公司报告称，美国食品药品管理局 (FDA)已授予posdinemab 快速通道资格，posdinemab 是一种针对磷酸化 tau 的单克隆抗体 (mAb)，用于治疗早期阿尔茨海默病 (AD)。posdinemab 目前正在 2b 期“ AuTonomy ”临床试验中进行评估。该抗体由公司内部研发，已证明能够靶向接受治疗患者脑脊液中与疾病相关的磷酸化 tau，并抑制临床前疾病模型中 tau 聚集体的形成和扩散。

Phase 2b “ReTain” Trial Investigates JNJ-2056’s Potential to Delay Cognitive Decline in Alzheimer’s Disease

2b期“保留”试验研究了JNJ-2056延缓阿尔茨海默病认知能力下降的潜力

The FDA designed the Fast Track process to speed up the review of therapies that address serious conditions with high unmet needs, allowing patients to access treatments sooner. Posdinemab marks the second Fast Track designation Johnson & Johnson has received in 2024 for its Alzheimer’s disease portfolio.

美国食品和药物管理局（FDA）设计了快速通道流程，以加快对治疗方法的审查，以解决严重疾病和高度未满足的需求，使患者能够更快地获得治疗。Posdinemab标志着强生公司在2024年因其阿尔茨海默病投资组合而获得的第二个快速通道称号。

Similarly, in July 2024, the FDA also granted Fast Track designation to JNJ-2056, the company’s anti-tau active immunotherapy and the first active immunotherapy targeting tau in a preclinical Alzheimer’s disease population. .

同样，2024年7月，FDA还授予JNJ-2056快速通道指定，这是该公司的抗tau主动免疫疗法，也是第一种针对临床前阿尔茨海默病人群中tau的主动免疫疗法。。

The Phase 2b “

阶段2b“

ReTain

保留

” trial, currently enrolling participants, aims to assess JNJ-2056’s ability to stimulate the immune system to produce antibodies against pathological phosphorylated tau, with the objectives of delaying or preventing symptom onset and slowing disease progression.

“该试验目前正在招募参与者，旨在评估JNJ-2056刺激免疫系统产生针对病理性磷酸化tau的抗体的能力，目的是延缓或预防症状发作并减缓疾病进展。

“Posdinemab has the potential to slow the spread of tau pathology in the brain – which may slow cognitive decline. The FDA’s Fast Track designation reflects the urgent unmet need for new treatment options for the millions living with AD,” stated Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine..

强生创新医学公司神经科学全球治疗领域负责人比尔·马丁博士表示：“Posdinemab有可能减缓tau病理在大脑中的传播，这可能会减缓认知能力的下降。FDA的快速通道指定反映了数百万AD患者迫切需要新的治疗选择。”。。

55 Million People Affected by Dementia and Evolving Diagnostic Criteria Including Cognitive Impairment

5500万痴呆症患者和不断发展的诊断标准，包括认知障碍

Approximately

大约

55 million people worldwide

全球5500万人

are affected by dementia, with Alzheimer’s disease representing 60–80 percent of these cases. AD is a neurodegenerative condition that gradually causes memory loss and other cognitive impairments, progressively interfering with daily activities. As the disease advances, patients often require continuous care, and it ultimately leads to death..

患有痴呆症，其中阿尔茨海默病占60-80%。AD是一种神经退行性疾病，逐渐导致记忆丧失和其他认知障碍，逐渐干扰日常活动。随着疾病的发展，患者通常需要持续护理，最终导致死亡。。

Researchers ground the diagnostic criteria for AD in established classifications; however’ they continue to evolve with ongoing

研究人员将AD的诊断标准纳入既定分类；然而，“他们继续发展

studies

研究

. In particular, preclinical AD refers to individuals who show detectable Alzheimer’s pathology, including amyloid and tau, yet remain cognitively unimpaired. Moreover, early Alzheimer’s disease encompasses those with mild cognitive impairment due to Alzheimer’s disease (prodromal AD) as well as individuals with mild Alzheimer’s dementia..

特别是，临床前AD是指表现出可检测到的阿尔茨海默病病理的个体，包括淀粉样蛋白和tau蛋白，但在认知上仍未受损。此外，早期阿尔茨海默氏病包括那些由于阿尔茨海默氏病（前驱AD）引起的轻度认知障碍患者以及轻度阿尔茨海默氏痴呆患者。。

In line with this vision, Johnson & Johnson is developing posdinemab. This investigational monoclonal antibody binds to pathological phosphorylated tau when released from neurons and neutralizes it before it can spread to other neurons. Furthermore, the compound has shown potential in reducing tau seeding in both in vitro and in vivo preclinical studies.

根据这一愿景，强生公司正在开发posdinemab。这种研究性单克隆抗体从神经元释放时与病理性磷酸化tau结合，并在其扩散到其他神经元之前将其中和。此外，该化合物在体外和体内临床前研究中均显示出减少tau接种的潜力。

The Phase 2b “AuTonomy” study, investigating the use of posdinemab in participants with early Alzheimer’s disease, has completed enrollment and is currently ongoing..

2b期“自主性”研究调查了早期阿尔茨海默氏病参与者使用posdinemab的情况，该研究已完成登记，目前正在进行中。。

“As the average age of the global population increases, the number of people impacted by this debilitating progressive disease continues to rise. Alzheimer’s disease places a substantial emotional and financial burden on patients and their loved ones and has a significant economic and societal impact.

“随着全球人口平均年龄的增长，受这种使人衰弱的进行性疾病影响的人数继续增加。阿尔茨海默病给患者及其亲人带来了巨大的情绪和经济负担，并产生了重大的经济和社会影响。

At J&J, we envision a future where we can help stop the progression of AD the moment it’s detected,” reemphasized Bill Martin..

在强生，我们设想了一个未来，我们可以在检测到AD的那一刻帮助阻止它的发展，”比尔·马丁再次强调。。