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更新于：2026-02-07
Zagotenemab
更新于：2026-02-07
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非在研机构 |
权益机构- |
最高研发阶段终止临床2期 |
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结构/序列
Sequence Code 10218609L
来源: *****
Sequence Code 10218629H
来源: *****
关联
4
项与 Zagotenemab 相关的临床试验NCT03518073
Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
JPRN-jRCT2080223501
Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease (I8G-MC-LMDD)
NCT03019536
Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
100 项与 Zagotenemab 相关的临床结果
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100 项与 Zagotenemab 相关的转化医学
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100 项与 Zagotenemab 相关的专利（医药）
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7
项与 Zagotenemab 相关的文献（医药）2025-06-01Nature Chemical Biology
Facile generation of drug-like conformational antibodies specific for amyloid fibrils
Article
作者: Zupancic, Jennifer M ; Chen, Hongwei ; Sharkey, Lisa M ; Trzeciakiewicz, Hanna ; Gerson, Julia E ; DuBois, Kelly N ; Tessier, Peter M ; Huang, Jie ; Desai, Alec A ; Smith, Matthew D ; Kanaan, Nicholas M ; Kane, Ravi S ; Skinner, Mary E ; McArthur, Nikki ; Makowski, Emily K ; Paulson, Henry L ; Kuo, Yun-Huai ; Ferris, Sean P ; Bhatt, Nemil N ; Jerez, Cynthia
Antibodies that recognize insoluble antigens, such as amyloid fibrils associated with neurodegenerative disorders, are important for research, diagnostic and therapeutic applications. However, these types of antibodies are difficult to generate, typically require animal immunization and also commonly require humanization in the case of therapeutic applications. Here we report a methodology for generating high-quality, fully human, conformation-specific antibodies against amyloid fibrils using a published human nonimmune library, yeast-surface display and quantitative fluorescence-activated cell sorting. Notably, this approach enables the isolation of conformation-specific antibodies against tau fibrils (Alzheimer's disease) and α-synuclein fibrils (Parkinson's disease) with combinations of high affinity, high conformational specificity and, in some cases, low off-target binding that rival or exceed those of clinical-stage antibodies specific for tau (zagotenemab) and α-synuclein (cinpanemab). This approach is expected to simplify the generation of conformation-specific antibodies against diverse protein aggregates and other insoluble antigens.
2024-03-12Neurology
Assessment of Efficacy and Safety of Zagotenemab
Article
作者: Andersen, Scott W. ; Munsie, Leanne M. ; Perahia, David G.S. ; Fleisher, Adam S. ; Sims, John R. ; Mintun, Mark ; Brys, Miroslaw ; Hauck, Paula M. ; Higgins, Ixavier A. ; Lo, Albert C.
BACKGROUND AND OBJECTIVES:
Zagotenemab (LY3303560), a monoclonal antibody that preferentially targets misfolded, extracellular, aggregated tau, was assessed in the PERISCOPE-ALZ phase 2 study to determine its ability to slow cognitive and functional decline relative to placebo in early symptomatic Alzheimer disease (AD).
METHODS:
Participants were enrolled across 56 sites in North America and Japan. Key eligibility criteria included age of 60-85 years, Mini-Mental State Examination score of 20-28, and intermediate levels of brain tau on PET imaging. In this double-blind study, participants were equally randomized to 1,400 mg or 5,600 mg of zagotenemab, or placebo (IV infusion every 4 weeks for 100 weeks). The primary outcome was change on the Integrated AD Rating Scale (iADRS) assessed by a Bayesian Disease Progression model. Secondary measures include mixed model repeated measures analysis of additional cognitive and functional endpoints as well as biomarkers of AD pathology.
RESULTS:
A total of 360 participants (mean age = 75.4 years; female = 52.8%) were randomized, and 218 completed the treatment period. Demographics and baseline characteristics were reasonably balanced among arms. The mean disease progression ratio (proportional decline in the treated vs placebo group) with 95% credible intervals for the iADRS was 1.10 (0.959-1.265) for the zagotenemab low-dose group and 1.05 (0.907-1.209) for the high-dose, where a ratio less than 1 favors the treatment group. Secondary clinical endpoint measures failed to show a drug-placebo difference in favor of zagotenemab. No treatment effect was demonstrated by flortaucipir PET, volumetric MRI, or neurofilament light chain (NfL) analyses. A dose-related increase in plasma phosphorylated tau181 and total tau was demonstrated. Zagotenemab treatment groups reported a higher incidence of adverse events (AEs) (85.1%) compared with the placebo group (74.6%). This difference was not attributable to any specific AE or category of AEs.
DISCUSSION:
In participants with early symptomatic AD, zagotenemab failed to achieve significant slowing of clinical disease progression compared with placebo. Imaging biomarker and plasma NfL findings did not show evidence of pharmacodynamic activity or disease modification.
TRIAL REGISTRATION INFORMATION:
ClinicalTrials.gov: NCT03518073.
CLASSIFICATION OF EVIDENCE:
This study provides Class II evidence that for patients with early symptomatic AD, zagotenemab does not slow clinical disease progression.
2023-11-01Journal of Alzheimer's disease reports
Safety, Tolerability, and Pharmacokinetics of Zagotenemab in Participants with Symptomatic Alzheimer’s Disease: A Phase I Clinical Trial
Article
作者: Scott W. Andersen ; Brian A. Willis ; Albert C. Lo ; Jeffrey L. Dage ; Stephen L. Lowe ; Louise Chinchen ; Elizabeth S. LaBell ; Sergey Shcherbinin ; Paula M. Hauck ; David G.S. Perahia
Background::
Zagotenemab (LY3303560), a monoclonal antibody, preferentially binds to extracellular, misfolded, aggregated tau that has been implicated in Alzheimer’s disease (AD).
Objective::
The goal of this study was to assess the safety and pharmacokinetics of multiple doses of zagotenemab in participants with AD.
Methods::
This was a Phase Ib, multi-site, participant- and investigator-blind, placebo-controlled, parallel-group study in participants with mild cognitive impairment due to AD or mild to moderate AD. After screening, participants were randomized to zagotenemab 70 mg, 210 mg, or placebo every 4 weeks for up to 49 weeks and were followed up for 16 weeks.
Results::
A total of 13 males and 9 females, aged 59 to 84 years, were dosed. No deaths occurred during this study. A total of 4 serious adverse events occurred in 2 participants who then discontinued the study. The most commonly reported (3 or more participants) treatment-emergent adverse events were sinus bradycardia, headache, fall, and bronchitis. The pharmacokinetics profile showed generally linear exposures across the dose range studied with a clearance of ~8 mL/h. The half-life of zagotenemab in serum was ~20 days. A dose-dependent increase in plasma tau was observed. No other significant pharmacodynamic differences were observed due to low dose levels and limited treatment duration.
Conclusions::
No dose-limiting adverse events were observed with zagotenemab treatment. Pharmacokinetics of zagotenemab were typical for a monoclonal antibody. Meaningful pharmacodynamic differences were not observed. Clinicaltrials.gov: NCT03019536
11
项与 Zagotenemab 相关的新闻（医药）2026-01-29
临床3期上市批准抗体药物偶联物加速审批申请上市
2025-12-16
临床1期临床2期临床结果
2025-12-16
引进/卖出临床1期并购临床2期临床申请
100 项与 Zagotenemab 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11533 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阿尔茨海默症 | 临床2期 | 美国 | 2018-04-30 | |
| 阿尔茨海默症 | 临床2期 | 日本 | 2018-04-30 | |
| 阿尔茨海默症 | 临床2期 | 加拿大 | 2018-04-30 | |
| 轻度认知障碍 | 临床1期 | 美国 | 2017-01-31 | |
| 轻度认知障碍 | 临床1期 | 日本 | 2017-01-31 | |
| 轻度认知障碍 | 临床1期 | 英国 | 2017-01-31 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 360 | Zagotenemab 1,400 mg | 廠襯簾願獵築艱齋膚簾(艱壓餘選選膚衊糧鏇壓) = 淵膚壓憲壓網鑰淵觸顧 築繭獵範廠遞鹽窪簾齋 (襯憲築顧鏇繭鑰選壓觸 ) | 不佳 | 2024-03-12 | ||
Zagotenemab 5,600 mg | 廠襯簾願獵築艱齋膚簾(艱壓餘選選膚衊糧鏇壓) = 壓醖鏇鏇積餘獵淵醖構 築繭獵範廠遞鹽窪簾齋 (襯憲築顧鏇繭鑰選壓觸 ) | ||||||
临床1期 | 阿尔茨海默症 plasma tau | - | Zagotenemab 70mg | 願糧築願網艱網窪窪憲(願構餘鏇夢觸憲遞淵膚) = The most commonly reported (3 or more participants) treatment-emergent adverse events were sinus bradycardia, headache, fall, and bronchitis 壓蓋艱糧選衊襯選鹹蓋 (鹹膚壓廠鏇齋醖夢觸憲 ) 更多 | 积极 | 2023-11-01 | |
临床1期 | 22 | (Placebo IV) | 簾觸壓鹽獵選遞襯艱鏇 = 衊蓋醖鏇選衊醖襯艱積 淵獵構積淵觸遞蓋鹽鬱 (夢蓋築製蓋膚鬱獵鹽齋, 獵簾艱廠壓廠膚廠齋觸 ~ 鏇繭遞窪製襯鏇遞願膚) 更多 | - | 2023-10-10 | ||
(70 mg LY3303560) | 簾觸壓鹽獵選遞襯艱鏇 = 蓋壓齋壓夢網襯觸網鹽 淵獵構積淵觸遞蓋鹽鬱 (夢蓋築製蓋膚鬱獵鹽齋, 鑰憲窪衊願鑰衊鏇衊觸 ~ 蓋觸簾簾鏇鑰製蓋廠鹹) 更多 | ||||||
临床2期 | 360 | Placebo (Placebo) | 獵蓋艱膚窪鑰憲鏇簾廠(窪鹹顧齋顧範廠簾夢壓) = 築築壓廠壓選顧襯衊窪 鬱夢憲簾鏇鬱構糧遞顧 (糧構膚網築鏇醖襯繭衊, 壓願淵獵願艱鬱鏇選觸 ~ 願艱鏇鑰築膚憲壓遞簾) 更多 | - | 2022-08-30 | ||
(Zagotenemab 1400 mg) | 獵蓋艱膚窪鑰憲鏇簾廠(窪鹹顧齋顧範廠簾夢壓) = 範餘製廠齋鹹網積繭醖 鬱夢憲簾鏇鬱構糧遞顧 (糧構膚網築鏇醖襯繭衊, 繭製襯願製壓醖鹽觸夢 ~ 範壓製淵遞願網鹽壓淵) 更多 |
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