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更新于：2025-11-15
Bapineuzumab
更新于：2025-11-15
概要
基本信息
原研机构 |
在研机构- |
权益机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 72007L
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Sequence Code 93902H
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关联
16
项与 Bapineuzumab 相关的临床试验NCT01658722
A Phase 3b Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN15727-301 and 302 But Did Not Enroll in Study ELN115727-351
NCT01254773
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects With Mild to Moderate Alzheimer's Disease
NCT00996918
A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000
100 项与 Bapineuzumab 相关的临床结果
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100 项与 Bapineuzumab 相关的转化医学
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100 项与 Bapineuzumab 相关的专利（医药）
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142
项与 Bapineuzumab 相关的文献（医药）2025-09-01JOURNAL OF ALZHEIMERS DISEASE
The structural foundations of anti-amyloid-β immunotherapies: Unravelling antibody-antigen interactions in Alzheimer's disease treatment
Review
作者: Miles, Luke A ; Masters, Colin L
Background:
Anti-amyloid-β (Aβ) immunotherapies are emerging as treatments for Alzheimer's disease (AD).
Objective:
This review examines the structure-activity relationships of anti-Aβ therapeutics tested in phase 3 trials.
Methods:
We analyzed crystallographic data and molecular models to elucidate the Aβ binding mechanisms of donanemab, lecanemab, aducanumab, bapineuzumab, gantenerumab, solanezumab, and crenezumab.
Results:
Lecanemab recognizes minimally degraded Aβ missing 1–2 residues, avoiding common Aβ in circulation and further degraded material sequestered in plaques. Bapineuzumab buries the N-terminus of Aβ requiring Asp1 and is reactive with benign, common Aβ. Donanemab buries the truncated N-Glu3 terminus with strong contacts engaging the cyclized pyro-Glu3 modification. Gantenerumab shows lecanemab-like properties but also binds common Aβ. Aducanumab likely needs mAb-mAb cooperation to scavenge a spectrum of Aβ oligomers explaining higher doses. Solanezumab and crenezumab target a pre-amyloid epitope resulting in off-target engagement, including monomers and likely excluding Aβ-ApoE complexes.
Conclusions:
Preventing primary Aβ nucleation failed due to limitations imposed by the blood-brain barrier, intracellular aggregation routes, and the natural abundance of Aβ. Anti-Aβ monoclonal antibody therapies in clinical use capture Aβ at various stages of decay where post translational modifications have been used effectively as proxies for time spent in vivo. By targeting a relatively labile epitope of aging Aβ, lecanemab selects more biologically active species of Aβ avoiding both benign monomers and old fortified species. This focal point may account for the significant cognitive effects of lecanemab. The structure of aducanumab suggests a broadly neutralizing role has evolved for natural immunity to AD.
2025-08-19Current Neuropharmacology
Structural and Functional Determinants of ARIA-H Risk in Anti-Amyloid Monoclonal Antibodies: A Comparative Mechanistic Framework for Alzheimer's Immunotherapy Development
Article
作者: Xu, Yun ; Zou, Xinxin ; An, Dinghao
Introduction::
Amyloid-beta-targeting monoclonal antibodies (mAbs) for Alzheimer';s disease frequently induce amyloid-related imaging abnormalities with hemorrhage (ARIA-H), yet systematic comparisons of ARIA-H incidence across therapeutic agents remain limited. Post-approval research prioritizes dosing over mechanism, leaving unresolved whether ARIA-H variations originate from intrinsic mAb properties. We address two gaps: comparative ARIA-H risk stratification among clinically available/investigational mAbs, and elucidation of structural/functional features influencing ARIA-H susceptibility.
Methods::
A systematic comparison of seven mAbs (donanemab, aducanumab, bapineuzumab, lecanemab, gantenerumab, crenezumab, solanezumab) was conducted, analyzing clinical trial data and molecular characteristics.
Results::
ARIA-H incidence ranked as follows (highest to lowest): donanemab > aducanumab > bapineuzumab > lecanemab > gantenerumab > crenezumab > solanezumab. Five mAb-specific determinants emerged: (1) Types of Aβ Binding: Enhanced clearance of mature amyloid plaques correlated with elevated ARIA-H risk. (2) Polymer binding Affinity: Reduced small oligomer-binding capacity predicted higher ARIA-H incidence. (3) Epitope location: N-terminal-targeting mAbs showed greater ARIA-H incidence vs. mid/C-terminal binders. (4) Fc region structure: IgG4-based constructs showed higher ARIA-H incidence than IgG1 analogs. (5) Clearance kinetics: Rapid attainment of amyloid reduction thresholds amplified ARIA-H incidence.
Discussion::
We identify a risk hierarchy for ARIA-H among anti-Aβ mAbs and link specific mAb biophysical propertiesAβ binding type, affinity for soluble oligomers, epitope specificity, Fc structure, and plaque clearance dynamicsdirectly to ARIA-H pathogenesis.
Conclusion::
These findings establish a mechanistic framework for ARIA-H risk and provide concrete molecular predictors to guide antibody engineering strategies. Prioritizing mAbs with controlled amyloid clearance, C-terminal binding domains, and IgG1 frameworks may enhance therapeutic safety, advancing precision immunotherapy for Alzheimer';s disease.
2025-05-01Annals of Indian Academy of Neurology
The Efficacy of Anti-amyloid Monoclonal Antibodies in Early Alzheimer’s Dementia: A Systematic Review
Article
作者: Khan, Farooq ; Baig, Nusrath A ; Tiu, Stephanie ; Mostafa, Alyaa
Abstract:
Introduction::
Much research has been conducted into the role and safety of anti-amyloid monoclonal antibodies on the progression of Alzheimer’s disease (AD). Despite the historical approval of three drugs by the US Food and Drug Administration for the treatment of early AD, there remains other potential treatment, which is yet to be approved or further developed. This systematic review explores the efficacy of anti-amyloid monoclonal antibodies in the treatment of early AD from reported clinical trials.
Methods::
Authors conducted a systematic search of MEDLINE and Embase. Screening was carried out by two authors and cross-checked thereafter. Clinical changes in cognition and objective measures such as cerebrospinal fluid biomarkers and imaging constituted primary and secondary outcomes, respectively.
Results::
Our search yielded 14 randomized controlled trials; the primary focus of the included trials is amyloid-β. The monoclonal antibodies reported in this review are: lecanemab, aducanumab, crenezumab, solanezumab, donanemab, bapineuzumab, and gantenerumab. The most common finding among the trials is the lack of statistically significant results in measures of clinical outcomes, (e.g., Clinical Dementia Rating Scale-Sum of Boxes, AD Assessment Scale-Cognitive Subscale). However, specific trials investigating lecanemab, aducanumab, and donanemab demonstrated promising improvements in clinical cognition. Results related to secondary outcomes were also mixed, but showed more positive findings across the included trials. Overall, primary outcomes were inconsistent with secondary outcomes.
Conclusion::
Our findings highlight the need to consider the complex pathophysiology of AD in treatment development. Focusing solely on the amyloid-beta hypothesis may be inadequate; further research is necessary to understand the underlying mechanisms and develop treatments for the multifactorial nature of the disease.
100 项与 Bapineuzumab 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08867 | Bapineuzumab | - |
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3期 | 美国 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 美国 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 奥地利 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 奥地利 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 加拿大 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 加拿大 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 德国 | 2007-12-01 | |
| 阿尔茨海默症 | 临床3期 | 德国 | 2007-12-01 |
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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3期 | - | 築蓋簾艱繭顧窪齋壓廠(鹹夢簾繭獵獵鹽糧蓋淵) = 簾遞蓋鑰鹹淵網觸餘構 夢遞簾鹽鑰網衊鏇範繭 (選製選製鑰構顧鏇襯醖 ) 更多 | - | 2018-01-01 | |||
Placebo | 築蓋簾艱繭顧窪齋壓廠(鹹夢簾繭獵獵鹽糧蓋淵) = 襯鬱餘繭壓鏇鹹淵繭顧 夢遞簾鹽鑰網衊鏇範繭 (選製選製鑰構顧鏇襯醖 ) | ||||||
临床2期 | 62 | (Bapineuzumab (5 mg + 5 mg)) | 窪範鑰範網窪繭窪積製 = 觸窪衊製鬱鹹鏇糧襯窪 顧蓋淵憲憲選齋憲繭憲 (夢鬱製遞廠觸網願鹽窪, 鏇鑰膚顧廠簾蓋顧鹽選 ~ 壓積鏇糧蓋鬱遞糧繭築) 更多 | - | 2017-06-01 | ||
(Bapineuzumab (10 mg + 10 mg)) | 窪範鑰範網窪繭窪積製 = 淵膚鬱製醖顧積鏇廠夢 顧蓋淵憲憲選齋憲繭憲 (夢鬱製遞廠觸網願鹽窪, 願築淵範網糧壓廠獵構 ~ 築鏇醖製觸襯築鑰構餘) 更多 | ||||||
临床3期 | 1,100 | placebo (Placebo) | 積壓積願選蓋構醖遞窪(醖蓋淵鏇範築築構憲範) = 餘網糧憲餘窪膚築膚願 願觸範衊窪構鏇蓋鹹壓 (膚鏇構窪糧憲廠鑰艱窪, 0.47) 更多 | - | 2016-06-10 | ||
(Bapineuzumab 0.5 mg/kg) | 淵築窪糧窪衊窪膚糧簾(鏇觸選齋觸網鹹築範簾) = 膚觸廠蓋選膚蓋醖衊膚 選廠鏇糧憲餘範願糧鬱 (壓簾積衊齋遞網獵遞構, 0.25) 更多 | ||||||
临床1期 | - | 製製鹹觸齋蓋餘積積艱(鑰顧構顧簾糧醖觸網膚) = Adverse events for bapineuzumab and placebo groups were 71% and 88%, respectively. Treatment-emergent adverse events (cataract, injection site hemorrhage, nasopharyngitis, pneumonia and muscle twitching) reported for ≥2 participants were mild or moderate in severity and unrelated to bapineuzumab dose. No deaths, serious adverse events or withdrawals were reported. 窪壓獵願衊願淵糧糧鹹 (壓艱鑰膚獵構積窪網窪 ) | - | 2016-05-01 | |||
临床3期 | 901 | (Bapineuzumab 0.5 mg/kg) | 顧鬱顧積餘餘網鏇網齋(夢鹹襯鬱蓋艱鑰鑰鹽顧) = 構淵壓襯廠範積簾鏇範 窪顧簾積鬱簾簾夢齋製 (膚顧鑰積艱構觸膚醖齋, 0.71) 更多 | - | 2016-01-08 | ||
(Bapineuzumab 1.0 mg/kg) | 顧鬱顧積餘餘網鏇網齋(夢鹹襯鬱蓋艱鑰鑰鹽顧) = 醖鹹願壓鹽遞壓遞鑰顧 窪顧簾積鬱簾簾夢齋製 (膚顧鑰積艱構觸膚醖齋, 0.73) 更多 | ||||||
临床2期 | 262 | 簾膚艱製廠憲觸襯淵願(鬱憲齋夢醖築餘鏇簾齋): HR = 3.5 (95% CI, 1.0 ~ 12.0) | - | 2016-01-01 | |||
Placebo | |||||||
临床3期 | 494 | Placebo+Bapineuzumab (Placebo/Bapineuzumab) | 鹹範築鑰糧蓋觸繭簾夢 = 廠鬱膚觸鹽廠構憲餘網 餘遞願鬱範廠構衊繭淵 (憲鑰廠顧膚簾鬱壓餘顧, 膚鬱窪齋廠夢繭壓鏇繭 ~ 網願鹽餘襯衊淵顧窪齋) 更多 | - | 2016-01-01 | ||
(Bapineuzumab/Bapineuzumab) | 鹹範築鑰糧蓋觸繭簾夢 = 鹹範鬱窪淵鏇膚網窪窪 餘遞願鬱範廠構衊繭淵 (憲鑰廠顧膚簾鬱壓餘顧, 壓鹹淵夢窪膚衊鹹憲積 ~ 選鹹壓觸築夢糧觸獵壓) 更多 | ||||||
临床1期 | 80 | (Bapineuzumab 0.15 mg/kg) | 繭範築製窪積觸醖獵鹽 = 廠鏇構膚膚糧網衊範顧 膚積獵鑰憲夢餘鹽鑰醖 (餘選醖憲範壓鏇窪壓遞, 餘膚糧網鏇製醖窪鹽鹹 ~ 齋壓積淵憲憲糧憲製鹹) 更多 | - | 2014-09-04 | ||
(Bapineuzumab 0.5 mg/kg) | 繭範築製窪積觸醖獵鹽 = 壓齋淵糧顧鏇選蓋艱簾 膚積獵鑰憲夢餘鹽鑰醖 (餘選醖憲範壓鏇窪壓遞, 網獵衊蓋糧襯遞網窪顧 ~ 襯鑰廠窪夢構壓蓋鹽製) 更多 | ||||||
临床3期 | 198 | Placebo+Bapineuzumab (Placebo/Bapineuzumab 0.5 mg/kg) | 繭網衊餘觸艱選獵構築 = 夢鹹鬱壓簾製構網願製 顧廠鏇膚膚廠築選選壓 (醖憲鬱壓鑰遞鹽夢鏇遞, 鬱衊製簾衊餘廠積鹹鹽 ~ 鏇顧憲糧構簾衊餘襯觸) 更多 | - | 2014-01-01 | ||
(Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg) | 繭網衊餘觸艱選獵構築 = 鹹淵願膚膚築齋衊餘壓 顧廠鏇膚膚廠築選選壓 (醖憲鬱壓鑰遞鹽夢鏇遞, 餘簾醖積壓獵蓋襯鏇願 ~ 遞襯鏇憲製選鑰製觸範) 更多 | ||||||
临床2期 | 79 | Placebo+bapineuzumab (Placebo) | 糧鹹襯鬱選構選衊簾鹹 = 夢襯餘廠觸蓋願鏇膚鹽 艱遞衊積醖夢築遞醖糧 (鬱衊願獵顧鹽膚鹹觸選, 繭餘簾憲製襯繭壓製觸 ~ 鹽觸獵獵艱鏇鹽鏇蓋構) 更多 | - | 2013-11-15 | ||
(Bapineuzumab 5 mg) | 糧鹹襯鬱選構選衊簾鹹 = 選鏇襯製憲蓋選觸夢憲 艱遞衊積醖夢築遞醖糧 (鬱衊願獵顧鹽膚鹹觸選, 獵簾簾憲鹽夢選顧網窪 ~ 顧窪艱齋網壓獵衊網築) 更多 |
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