A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

开始日期2022-04-19

申办/合作机构

Hoffmann-La Roche, Inc.

CTR20210207

/ Completed临床1期

一项在健康中国受试者中考察单次腹部皮下注射GANTENERUMAB高浓度液体制剂后药代动力学、安全性和耐受性的单中心、开放性、I期研究

本研究将在健康中国受试者中评价G4工艺生产的gantenerumab在单次皮下注射510 mg剂量后的药代动力学、安全性和耐受性特征。 1. 药代动力学目的：根据以下终点，描述健康中国受试者单次SC注射（510 mg）gantenerumab的药代动力学特征： ● 主要PK参数：AUCinf和Cmax ● 次要PK参数：AUC0-672h、AUC0-last、t1/2（如下方法计算：ln 2/消除速率常数[λz]）、表观清除率（CL/F）、非静脉给药后的终末期分布容积（Vz/F） 2. 安全性目的根据以下终点，评价健康中国受试者单次SC注射（510 mg）gantenerumab的安全性和耐受性： ● 不良事件的性质、发生率、严重程度和因果关系 ● 使用视觉模拟量表（VAS）和言语评定量表（VRS）进行局部疼痛评估 ● 异常实验室检查结果、异常生命体征和异常心电图的发生率 ● ISR的发生率（局部和全身） 3. 免疫原性目的根据以下终点评价受试者对gantenerumab的免疫应答： ● 研究期间gantenerumab抗药抗体（ADA）发生率相对基线时ADA发生率的变化

开始日期2021-06-02

申办/合作机构

F. Hoffmann-La Roche Ltd.

[+1]

NCT04374253

/ Terminated临床3期

An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

开始日期2021-01-26

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与甘特鲁单抗相关的临床结果

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100 项与甘特鲁单抗相关的转化医学

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100 项与甘特鲁单抗相关的专利（医药）

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117

项与甘特鲁单抗相关的文献（医药）

2025-11-01·CNS & Neurological Disorders-Drug Targets

Trends in Research on Gantenerumab for Alzheimer’s Disease: A Bibliometric and Thematic Analysis

Article

作者: Taha, Manal Mohamed Elhassan ; Albasheer, Osama ; Ali, Sohaila ; Babiker, Yasir Osman Hassan ; Gohal, Gassem ; Farasani, Abdullah ; Abdelwahab, Siddig Ibrahim ; Alfaifi, Hassan Ahmad ; Aljahdali, Ieman A. ; Oraibi, Bassem ; Oraibi, Omar ; Alzahrani, Amal Hamdan ; Ahmed, Anas A. ; Jerah, Ahmed Ali

Background::

Gantenerumab (GR), a promising therapeutic agent for Alzheimer's disease (AD), has been the subject of extensive research. In this study, we aimed to provide a comprehensive analysis of the literature on GR.

Methods::

A systematic search was conducted using the PubMed, Scopus, and Web of Science databases. VOSviewer and Bibliometrix were utilized to analyze bibliographic data.

Results::

The analysis of the literature on GR revealed distinct publication trends. Reviews accounted for 52% of the records, followed by research articles (31%). The United States contributed the highest proportion of publications (26%). The Journal of Prevention of Alzheimer’s Disease was the most prolific source (21 articles). The annual number of publications increased steadily from 2009 to 2024. Major international collaborations were observed among the United States, the United Kingdom, Switzerland, France, and Sweden. Research activity consistently centered on key themes, such as amyloid imaging, biomarkers, clinical trials, and β-amyloid. Thematic mapping identified specialized subfields, core research areas, and dynamic shifts in topics, offering a comprehensive overview of the GR research landscape.

Conclusion::

GR-related literature showed sustained thematic focus, growing international collaboration, and a steady rise in publication volume within the field of AD. These findings highlight the continued need for clinical and biomarker-focused investigations to advance therapeutic development in AD.

2025-09-01·JOURNAL 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.

2025-09-01·Alzheimers & Dementia

The relationship of soluble tau species with Alzheimer's disease amyloid plaque removal and tau pathology

Article

作者: Fox, Nick C. ; Day, Gregory S. ; Wang, Guoqiao ; Gordon, Brian ; Ikeuchi, Takeshi ; Vöglein, Jonathan ; Perrin, Richard J. ; Benzinger, Tammie L. S. ; Masellis, Mario ; Cruchaga, Carlos ; Barthélemy, Nicolas R. ; Ibáñez, Laura ; Jucker, Mathias ; Lah, James ; Morris, John C. ; McDade, Eric M. ; Levey, Allan I. ; Chhatwal, Jasmeer ; Clifford, David ; Lee, Jae‐Hong ; Xiong, Chengjie ; Goate, Alison M. ; Supnet‐Bell, Charlene ; Masters, Colin L. ; Bateman, Randall J. ; Yaari, Roy ; Suzuki, Kazushi ; Llibre‐Guerra, Jorge J. ; Li, Yan ; Mummery, Catherine J. ; Wallon, David ; Bittner, Tobias ; Gauthier, Serge ; Roberson, Erik D. ; Daniels, Alisha ; Cao, Yuchen ; Schofield, Peter ; Van Dyck, Christopher ; Sánchez‐Valle, Raquel ; Brooks, William ; Chrem, Patricio ; Karch, Celeste ; Hassenstab, Jason ; Roh, Jee Hoon ; Levin, Johannes J. ; Berman, Sarah B. ; Renton, Alan E. ; Ringman, John ; Ryan, Natalie S.

Abstract:

BACKGROUND:

Tau‐derived cerebrospinal fluid (CSF) biomarkers correlate with amyloid‐beta (Aβ) plaques or tau tangles in Alzheimer's disease (AD). This study assessed the effects of long‐term anti‐Aβ antibodies on amyloid plaques, tau tangles, and CSF tau species to determine the relationships between them.

METHODS:

A post‐hoc analysis of the DIAN‐TU‐001 trial (NCT01760005) examined 142 participants at risk for dominantly inherited AD randomized to solanezumab (n = 50), gantenerumab (n = 52), or placebo (n = 40). High‐resolution mass spectrometry quantified CSF tau species over four years.

RESULTS:

Phosphorylated tau (p‐tau) species (153, 181, 217, 231) increased early in preclinical AD but were reduced with gantenerumab‐mediated Aβ plaque reduction. Nearly a decade later, MTBR‐tau243 and p‐tau205 increased, showing no association with Aβ reduction, aligning with tau tangle pathology progression.

DISCUSSION:

Initially changing soluble p‐tau species track Aβ plaque reduction, while ptau205 and MTBR‐243 reflect tau tangle pathology, informing different pathways of therapeutic strategies.

Highlights:

p‐tau217 and p‐tau231 correlate with Aβ‐PET and respond to Aβ‐plaque lowering therapies.Aβ immunotherapy trials support a direct link between p‐tau changes and Aβ plaquesGantenerumab reduces Aβ plaques but does not affect tau NFT‐related biomarkers.Blood‐based p‐tau217 assays may provide a non‐invasive tool to monitor Aβ therapies.MTBR‐tau243 strongly correlates with tau PET and tracks NFT pathology progression.Further studies are needed to validate tau biomarkers for tracking NFT‐targeting therapies.

299

项与甘特鲁单抗相关的新闻（医药）

2025-09-25

·医药经济报

石药进军AD百亿蓝海，直指卫材/渤健！恒瑞、先声等群雄逐鹿

阿尔兹海默病（AD）百亿赛道烽烟再起，卫材与渤健将面对石药这位强劲对手，国内外诸多企业也接踵而至加入新一轮的竞逐。 9月25日，石药集团发布公告，其开发的仑卡奈单抗注射液获得国家药监局批准，可在中国开展临床试验。该产品按照治疗用生物制品3.3类申报，适用于治疗由AD引起的轻度认知障碍和AD轻度痴呆。值得注意的是，该药为国内首个获得临床许可的仑卡奈单抗注射液生物类似药。 AD领域的市场需求一直以来都吸引着众多MNC巨头的目光，但在投入巨额资金后却大多以失败告终的局面一度让AD药物被业界称为“研发黑洞”。即便如此，巨大的市场潜力也引来越来越多的企业入局，领跑者已然打开了这座“金矿”尘封已久的大门。此前，卫材/渤健与礼来的市场争夺战一度焦灼，未来还将迎来石药集团等国产选手的竞逐。 AD治疗新纪元石药发力破局原研 AD是一种常见的退行性神经疾病，其发病率随年龄增长而显著上升。据世界卫生组织（WHO）估计，2023年全世界有5500万AD患者；而随着全球人口老龄化不断加剧，到2050年，这一数字可能增加到1.3亿例，呈现出每20年翻倍的增长趋势，这将给患者、家庭以及社会带来更为沉重的负担。仑卡奈单抗注射液是一款靶向β-淀粉样蛋白（Aβ）的单克隆抗体，其全球开发和监管由日本卫材公司（Eisai）主导，并与美国渤健公司（Biogen）共同进行商业化和推广，卫材公司拥有最终决策权。 2023年7月，仑卡奈单抗注射液获批上市，成为20年来首款获得FDA完全批准的AD新疗法。2024年1月10日，原研仑卡奈单抗在国内获批上市。至此，中国成为继美国、日本之后第三个批准该药的国家。截至目前，仑卡奈单抗尚未被纳入国家医保目录，仍属于自费药物。米内网数据显示，2023年仑卡奈单抗的全球销售额为43亿日元，2024年涨至443亿日元（按即时汇率换算约为3亿美元），增长率高达930%。在中国三大终端六大市场，仑卡奈单抗2024年前三季度的销售额超过5000万元，2025年第一季度直接拿下了5300万元的成绩。仑卡奈单抗的核心临床优势在于它首次为早期AD患者提供了一种能够明确延缓疾病进展的病因治疗手段，将治疗目标从“缓解症状”提升到了“改变病程”的新高度，是具有里程碑意义的突破性疗法。当前，仑卡奈单抗在全球市场展现出强大的市场潜力，卫材和渤健也在不断拓展该药的使用场景。今年8月，卫材和渤健宣布，FDA已批准每周一次的仑卡奈单抗皮下自动注射（SC-AI）周维持剂量上市（美国商品名：LEQEMBI® IQLIK™），用于治疗早期AD。此次获批使仑卡奈单抗成为目前首款可在家中使用自动注射器进行皮下给药的AD治疗药物，整个注射过程平均仅需约15秒。截图来源：企业官网在神经系统药物领域有着深远布局的石药集团，或将成为卫材和渤健强劲的竞争对手。2024年在中国三大终端六大市场，石药集团是神经系统药物（化药+生物药）的TOP2集团，已获批的神经系统药物超过50个（按产品名统计），均为化学药，暂无生物药获批。目前，石药集团已拥有两款超10亿重磅产品，分别为丁苯酞氯化钠注射液和丁苯酞软胶囊。石药集团2024年神经系统药物TOP10产品情况注：销售额低于1亿元用*表示来源：米内网格局数据库值得注意的是，石药集团在神经系统药物市场布局的首款生物药1类新药是ALMB-0166注射液，目前该新药正在进行急性脊髓损伤I期临床，仑卡奈单抗注射液是石药集团布局的第二款神经系统生物药新药，此番临床申请获得默示许可味着石药集团向神经系统药物领域更进一步。 Aβ单抗引爆蓝海市场海内外力量竞合博弈据统计，2023年全球AD药物市场销售额已达136.2亿美元，预计到2034年将增长至314.4亿美元，期间年复合增长率约8.7%。中国市场增长更为迅猛，2023年市场销售额约为60亿元，预计到2030年有望突破260亿元，期间年复合增长率将保持在19.2% 的高位水平。 AD这一价值数百亿美元的市场，不仅吸引着MNC巨头的重金注入，也催生了中国本土创新力量的崛起，形成了仿创并存、多技术路线探索的动态竞争格局。从研发端来看，目前全球AD药物开发靶点集中在Aβ淀粉样蛋白、Tau蛋白以及胆碱酯酶（及其受体）等靶点，其中Aβ淀粉样蛋白为目前在研项目最多、最为前沿的创新药物靶点。据Insight数据库统计，筛选尚活跃的AD新药研发相关临床试验，截至2023年6月，我国共有44项临床研究，大部分集中在I期。10项III期临床试验包括礼来的Remternetug、Lanabecestat、Donanemab，罗氏的Gantenerumab，卫材的多奈哌齐和Lecanemab，神尔洋高的琥珀八氢氨吖啶等。在靶点上，14项临床试验都针对传统的AChE靶点。针对Aβ靶点的大多数研究均为跨国药企研发的药物。目前，全球抗痴呆药市场呈现出多极化竞争特点，主要参与者包括礼来、渤健、艾伯维等国际制药巨头，这些企业凭借其强大的研发实力、丰富的产品线和全球化的市场布局占据领先地位。紧随卫材/渤健之后的礼来于2023年7月向FDA提交了其开发的Aβ单抗Donanemab（多奈单抗）的新药上市申请。今年3月，礼来中国发布公告称，其用于AD疾病早期、靶向疾病病理机制、可显著减缓疾病进程的创新药多奈单抗注射液正式在中国上市。此前，该药作为1类新药、突破性疗法于2024年12月17日获NMPA批准，用于治疗成人因AD引起的轻度认知障碍（MCI）和AD轻度痴呆。除了多奈单抗，礼来旗下还有一款治疗AD的抗体疗法——Remternetug，正在中国进行III期临床研究。该药物提供静脉注射和皮下注射两种剂型，其中皮下注射剂型的给药方案为每周一次，极大地提高了给药的便利性。艾伯维同样是AD赛道的重要玩家。2024年10月，艾伯维以14亿美元现金收购Aliada公司，获得后者血脑屏障（BBB）穿透技术及管线ALIA-1758。公开资料显示，ALIA-1758是一种针对AD的抗焦谷氨酸化β淀粉样蛋白（3pE-Aβ）的抗体，目前ALIA-1758正在进行Ⅰ期临床试验。相较于中国庞大的AD患者人群，目前本土药企在AD研发上的投入还较少，主要源于前期各大跨国药企均折戟AD药物研发，整体研发难度较大。AD药物虽有“研发黑洞”之称，但面对巨大的市场潜力，目前国内各大药企也并没有放弃这一治疗领域。国内创新药龙头企业恒瑞医药也在该领域持续发力，其自主研发的Aβ单抗SHR-1707目前已进展至II期临床。2023年3月，据恒瑞医药介绍，SHR-1707注射液用于治疗早期AD的Ib期临床试验在中国科学技术大学附属第一医院完成了首例患者入组及给药。先声药业则是License-in了两款AD创新药，目前在国内AD研发上进展靠前。2021年6月，先声药业与Vivoryon达成超5亿美元的合作，获得相关药物在大中华区开发和商业化权益，并于2022年在国内获批临床试验。根据协议，先声药业将获许在大中华地区开发和商业化两种由Vivoryon公司开发的AD药物，分别是处于临床IIb期的靶向N3pE的口服小分子谷氨酰肽环转移酶（QPCT）抑制剂Varoglutamstat（PQ912）和处于临床前研究阶段的单克隆N3pE抗体PBD-C06。业内观点分析认为，目前AD治疗药物作为蓝海市场仍有较大的挖掘空间，随着业界对AD病理机制的深入理解，有望出现更多创新和有效的治疗方法，在为患者带来新希望的同时，也将拓展AD市场的更大发展空间和商业潜力。编辑：李咏诗版式编辑：陈淑文审校：马飞、张松同通用名不同剂型价差近70倍！四川百利被点名，药价治理再扩围减肥赛道“真香”！辉瑞三折戟后，豪掷70亿+美元再闯关新一轮国采席卷4.6万家医院！近八成报量锚定品牌，25款原研药激战 www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

上市批准生物类似药突破性疗法

2025-08-14

·药通社

971无了，还有中药！

8月12日，知名治疗阿尔兹海默症（AD）药物，甘露特纳胶囊（俗称971胶囊）被下发了通知件，依据受理号推断，应当是附条件审批转常规审批失败。相关文章：绿谷制药971，再注册失败！这款治疗阿尔茨海默病的争议性药物正式退出市场，而失败原因推测是IV期临床试验结果不佳。 971胶囊无了，那么其他治疗AD的药物，还有么？ ↓ 扫码加入药通社交流群 ↓ 971无了，还有中药！ 6月18日，华西医院招募阿尔茨海默症的中药创新药KH110（五加益智颗粒）临床III期受试者的消息传来，诸多患者要求入组参与试验。图源：药圈观察局相较于昂贵的单抗治疗，中药治疗AD，或许是新方法？事实上，国内一些中药创新药先驱企业早已开始行动。首先是上文提到的，康弘药业旗下四川济生堂自主研发的KH110（五加益智颗粒），现已进入临床III期。该药用于脾肾两虚所致痴呆，适用于轻、中度AD患者。主要疗效指标为治疗12个月后，与安慰剂组阿尔茨海默病评定量表-认知部分（ADAS-cog/12）评分及临床痴呆评定量表（CDR-SB）较基线改变的组间差异。与此同时，康缘医药正在进行苁蓉总苷胶囊治疗轻中度AD（髓海不足证）Ⅱ期临床试验。首例受试者已于2025年4月14日签署知情同意书，计划入组136例，主要评估阿尔茨海默病评价量表-认知子量表（ADAS-cog/11）认知评分变化及不良事件，评价周期为用药前至用药后24周。除此之外，北京恒清堂医药也在进行参芪醒脑颗粒治疗轻度阿尔茨海默病的Ⅱ期临床研究。主要终点为36周治疗结束后阿尔茨海默病评价量表-认知部分（ADAS-Cog）评分变化，目标入组160人，目前已完成入组。这之中，进度最快的是四川济生堂。时间分析，如果临床试验顺利，最早2026年底能有III期临床试验数据。预计完成临床之后，就会提交上市。这么看来，未来中药治AD或真将成为可能？放眼全球，AD市场到底有多庞大？答案是：平均每3秒增加1例患者。据WHO数据，2023年全球 AD 患者已超 5500 万，预计2050 年将增至 1.39 亿，每3秒就会增加1例患者。而中国是全球 AD 患者最多的国家。据中国阿尔茨海默病协会（ADC）2023 年统计，我国 AD 患者约 983 万，预计 2030 年将突破 1900 万。正因如此，AD庞大的患病人群吸引着各大企业争相研发，但结果却一言难尽。 2012年，强生/辉瑞的单抗药物Bapineuzumab的III期临床试验失败； 2014年，罗氏宣告Gantenerumab的III期临床试验失败； 2016年，礼来宣告III期临床药物Solanezumab没有达到主要临床终点； 2017年，默沙东宣布停止开发BACE抑制剂药物Verubecestat； 2018年，强生宣布其终止了BACE抑制剂剂Atabecestat II/III期临床试验...... 最接近成功的一次，是2021年6月，FDA批准卫材和渤健共同研发的Aduhelm终于成功上市，那是第一款基于Aβ级联的药物，也是第一款治疗AD本身的药物。然而虽然Aduhelm在美国顶着腥风血雨上市了，但因其存在明显副作用，且价格极其昂贵（年治疗费高达5.8万美金），上市后难以推广，最终卫材和渤健选择停止了Aduhelm的商业化进程。失败案例不胜枚举，也因此，阿尔茨海默病的新药研发被行业称作“地狱级”挑战，甚至被业内形容为“死亡之谷”，失败率高达99.6％。市场如此庞大，研发了这么多年，但AD治疗药物依然寥寥可数。截至目前，能够同时被美、欧、日、中多国所认可的早期AD治疗药物，却只有两款：一款是卫材和渤健的仑卡奈单抗；另一款是礼来的多奈单抗。 2023年1月，还是卫材和渤健，首次Aduhelm的研发成功让他们找到了AD药物的研究路径，也就是目前最被大众认可的基于淀粉样蛋白假说的研发路径。基于Aduhelm的经验，终于开发出了首款FDA完全批准的Aβ单抗药物（仑卡奈单抗），用于治疗早期AD患者，成为全球首个能延缓AD进程的药物。 2024年7月，礼来上市了第二款Aβ单抗药物，多奈单抗，一经上市就备受质疑，据实验数据显示多奈单抗副作用发生几率远高于仑卡奈单抗，今年7月，礼来更新了多奈单抗的给药方式，可有效降低副作用发生率。质疑声逐渐变小，但这两款药物还有一个最大的问题：治疗费用过于昂贵，在国内两款药都不进医保，对患者及其家属来说负担太重。过高价格导致这两款药在上市起质疑声就不断，且仑卡奈单抗和多奈单抗仅适用于早期AD患者，对于中、重度AD治疗依旧束手无策。 AD药物，各有各的难，未来之路，任重而道远！或许真的靠中药了？参考： [1]医耀—阿尔兹海默病走出“技术沉没周期” [2]药圈观察局—中药AD新药，已进入临床III期 [3]中种看药—阿尔茨海默病新药研发进展及康缘药业所处位置本文截图均来自：摩熵医药 ↓关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明企业及来意

临床2期临床3期抗体药物偶联物申请上市临床失败

2025-08-04

·EINPresswire

Biomed Industries Presents Four Breakthrough Studies on Alzheimer’s, Rett Syndrome, and Obesity Therapies at AAIC 2025

Biomed Industries, Inc. Presents Four Pivotal Studies at AAIC 2025 Highlighting Breakthrough Therapies for Alzheimer’s, Rett Syndrome, and Obesity NA-831 is the only drug to date that has halted Alzheimer’s disease progression. Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” — Dr. Lloyd L. Tran, CEO of Biomed SAN JOSE, CA, UNITED STATES, August 4, 2025 / EINPresswire.com / -- Biomed Industries, Inc., a leading biopharmaceutical innovator developing transformative therapies for neurological and metabolic diseases, today announced the presentation of four major scientific papers at the Alzheimer’s Association International Conference (AAIC), held July 27–31, 2025, in Toronto, Canada. The presentations featured Biomed’s next-generation oral therapies for Alzheimer’s disease, Rett syndrome, and obesity, with a focus on novel combination strategies designed to enhance safety, efficacy, and accessibility. Featured AAIC 2025 Presentations: 1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer’s Disease 2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind Study 3. Associations Between Alzheimer’s Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921 4. Neuro-Metabolic Link Between Alzheimer’s Disease and Obesity: Clinical Evaluation of NA-831 and NA-931 1. PRESENTATION: The End of the Amyloid Era? A Paradigm Shift in Alzheimer’s Research For over three decades, the “amyloid hypothesis” has dominated Alzheimer’s disease (AD) research, asserting that amyloid-β accumulation is a primary driver of neurodegeneration. Biomed’s comprehensive analysis of Phase 3 trial data from seven anti-amyloid drugs — including aducanumab, lecanemab, donanemab, gantenerumab, bapineuzumab, crenezumab, and solanezumab — challenges this paradigm. Across all trials, both treatment and placebo groups exhibited similar cognitive decline, as measured by CDR-SB and ADAS-Cog. The average differences between treatment and placebo arms were minor and not clinically significant (CDR-SB: -0.25; ADAS-Cog: -0.79). Slope comparisons further revealed near-identical rates of decline between groups. “Our analysis of Phase 3 clinical trial data for seven anti-amyloid drugs, including FDA-approved Aducanumab, Lecanemab, and Donanemab, indicates that none could halt disease progression in a clinically meaningful way — and all carried serious safety concerns,” said Dr. Zung Tran, VP of Biostatistics and AI at Biomed. 2. PRESENTATION: Phase 3 Clinical Protocol of NA-831 Combined with Donanemab NA-831, Biomed’s lead oral candidate, is a first-in-class therapy that promotes neuroprotection, neurogenesis, and memory enhancement. Phase 2 trials demonstrated its disease-modifying potential with a favorable safety profile compared to traditional anti-amyloid drugs. In this upcoming Phase 3 study, NA-831 will be evaluated in combination with Donanemab, a recently FDA-approved monoclonal antibody, to explore synergistic effects. The goal is to lower Donanemab dosing, thereby reducing risks such as cerebral edema and microbleeds, while enhancing cognitive outcomes. “NA-831 is the only drug to date that has halted disease progression in Phase 2 trials,” said Dr. Lloyd Tran, CEO of Biomed Industries. “Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” 3. PRESENTATION: Alzheimer’s and Rett Syndrome: Shared Mechanisms and Dual Therapeutic Potential Biomed also presented findings on NA-921, a structural analog of NA-831 developed for Rett syndrome, a rare X-linked neurodevelopmental disorder. NA-921 modulates MeCP2 expression, targeting the disorder’s core epigenetic dysfunction. A double-blind, placebo-controlled Phase 2/3 trial (ClinicalTrials.gov ID: NCT06849973) demonstrated promising results: Clinical Global Impression–Improvement (CGI-I) at week 12: NA-921: 3.60 | Placebo: 3.83 | P = 0.0020 | Effect size = 0.42 NA-921 was well tolerated, with a significantly improved safety profile compared to trofinetide: - Diarrhea: Trofinetide 82%, NA-921 24%, Placebo 19% - Vomiting: Trofinetide 29%, NA-921 9%, Placebo 11% - Fever: Trofinetide 9%, NA-921 5%, Placebo 4% These findings underscore a possible biological link between Alzheimer’s disease and Rett syndrome, opening new cross-indication opportunities for NA-831 and NA-921. 4. PRESENTATION: Neuro-Metabolic Connections: NA-831 and NA-931 in Alzheimer’s and Obesity Biomed’s data also revealed compelling evidence of a neuro-metabolic bridge between Alzheimer’s disease, diabetes, and obesity. In addition to NA-831’s CNS benefits, Biomed is advancing NA-931, an oral quadruple receptor agonist (IGF-1, GLP-1, GIP, and glucagon) designed to treat obesity. In a 13-week Multiple Ascending Dose (MAD) study: - Mean body weight reduction: Up to 13.8% at 150 mg daily, 12.4% greater than placebo - ≥12% weight loss achieved by 72% of NA-931-treated patients vs. 2% in placebo group NA-931 demonstrated a strong safety profile, with mild and transient GI-related adverse events, and no observed muscle loss. “Our pipeline shows how targeting interconnected pathways across the CNS and metabolic systems can unlock significant clinical potential,” said Michael Willis, VP of Business Development. “With six active programs across Alzheimer’s, ALS, Rett syndrome, stroke, obesity, and MASH, we are building a diversified platform to accelerate innovation and value creation.” ABOUT BIOMED INDUSTRIES, INC. Biomed Industries, Inc. is a pioneering biopharmaceutical company committed to developing novel therapeutics that address unmet medical needs. Its innovative research platform has produced treatments for conditions including Alzheimer’s disease, ALS, Traumatic Brain Injury, Major Depressive Disorder, Diabetes, Obesity, MASH, Stroke, and rare diseases such as Huntington Disease and Rett Syndrome. (Website: https://www.biomedind.com ) Michael Willis Biomed Industries, Inc. email us here Visit us on social media: LinkedIn X Biomed introduction video Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期临床3期

100 项与甘特鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09713	甘特鲁单抗	-	DB12034

研发状态

10 条进展最快的记录,

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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	阿根廷	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	智利	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	捷克	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	芬兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	荷兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	波兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	葡萄牙	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	瑞典	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	瑞士	Hoffmann-La Roche, Inc.	2010-11-30

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01760005 \| NCT06424236 (DIAN-TU-001, Pubmed) 人工标引	临床2/3期	阿尔茨海默症	74	gantenerumab (any gantenerumab)	壓積膚廠淵憲憲餘憲衊(願構醖積積構蓋遞鬱鏇) = At the interim analysis, the hazard ratio for clinical decline of CDR-SB in asymptomatic mutation carriers was 0·79 (n=53 [95% CI 0·47 to 1·32]) for participants who were treated with gantenerumab in either the double-blind or OLE period (Any Gant), and 0·53 (n=22 [0·27 to 1·03]) for participants who were treated with gantenerumab the longest (Longest Gant). 遞鏇蓋獵鹹廠憲壓憲願 (獵鹹衊醖鏇壓選艱顧製 ) 更多	积极	2025-04-01
				gantenerumab (Longest gantenerumab)
NCT06424236 (DIAN-TU, CTgov)	临床2/3期	阿尔茨海默症	73	OLE+Gantenerumab (Double-blind Placebo - OLE Gantenerumab)	膚夢願獵願觸繭膚糧選(鹽醖觸顧窪鹹鹽願獵醖) = 鹽網簾壓選糧願窪獵艱衊糧積獵淵範鹽鬱夢簾 (廠製憲遞淵鑰觸窪範齋, 0.22606) 更多	-	2025-02-04
				Gantenerumab+Solanezumab (Double-blind Solanezumab - OLE Gantenerumab)	膚夢願獵願觸繭膚糧選(鹽醖觸顧窪鹹鹽願獵醖) = 廠築齋願簾觸廠憲鹹鏇衊糧積獵淵範鹽鬱夢簾 (廠製憲遞淵鑰觸窪範齋, 0.40538) 更多
NCT03443973 \| NCT03444870 \| NCT04374253 (GRADUATE I/II, Pubmed \| JAMA Neurol)	临床3期	阿尔茨海默症 Fazekas score \| total superficial siderosis count \| total microhemorrhage count ... 更多	1,939	Gantenerumab	憲遞築憲窪選糧窪壓齋(觸製廠選範顧觸窪蓋獵) = 鹹淵選鬱憲觸顧醖鹹醖襯鹽蓋網鏇範壓糧鏇遞 (選選襯觸衊選壓鹹製觸 ) 更多	积极	2024-11-18
NCT05256134 (SKYLINE, CTgov)	临床3期	阿尔茨海默症	25	Placebo (Placebo)	鬱鏇鑰製齋鏇憲鹹鏇網(獵簾鹹鹽鬱積壓願廠糧) = 廠積壓襯膚選顧鑰鬱鹹鹹鹽鹹願築淵艱淵憲餘 (糧淵觸築齋蓋壓獵憲蓋, 0.5790) 更多	-	2024-07-09
				Gantenerumab (Gantenerumab)	鬱鏇鑰製齋鏇憲鹹鏇網(獵簾鹹鹽鬱積壓願廠糧) = 窪鑰憲鹽衊夢夢鑰齋鬱鹹鹽鹹願築淵艱淵憲餘 (糧淵觸築齋蓋壓獵憲蓋, 0.6038) 更多
NCT04374253 (CTgov)	临床3期	阿尔茨海默症	1,382	Placebo (Placebo: Participated in Graduate OLE)	獵鹽齋製遞齋積繭願顧 = 鏇鬱繭簾憲襯衊窪顧醖範鏇簾鹽壓鹽簾夢獵選 (鹹醖鹽選蓋繭餘觸憲艱, 願蓋衊網簾糧選獵鬱範 ~ 顧蓋膚選積艱餘艱淵廠) 更多	-	2024-05-08
				Placebo (Placebo: No Participation in Graduate OLE)	獵鹽齋製遞齋積繭願顧 = 餘鑰醖選鹽窪觸構鹹齋範鏇簾鹽壓鹽簾夢獵選 (鹹醖鹽選蓋繭餘觸憲艱, 糧糧願觸淵遞築願窪繭 ~ 鏇顧獵壓構壓鏇鑰願壓) 更多
NCT04623242 (Pubmed)	临床2/3期	阿尔茨海默症	-	Solanezumab	構獵顧構鑰願製糧蓋齋(構構廠膚網選憲壓蓋獵) = 遞廠壓鏇遞艱網簾衊繭膚廠淵窪襯繭鬱餘獵鬱 (積憲範衊壓鏇壓構顧積, 0.43)	-	2024-04-29
NCT04592341 (CTgov)	临床2期	阿尔茨海默症	192	Gantenerumab	觸齋壓齋艱構製衊糧網(願膚製襯鹹選壓繭鏇觸) = 顧網築鏇壓衊簾鹹醖鏇築積鬱構鏇遞醖製壓觸 (繭積築顧製餘獵蓋積齋, 29.80) 更多	-	2024-03-27
NCT03444870 (CTgov)	临床3期	阿尔茨海默症	1,053	placebo+gantenerumab (Global - DBT Period: Placebo)	鹹夢築顧醖遞選衊鬱簾(夢繭鹹鹹齋窪簾艱襯簾) = 壓簾艱鬱夢蓋積廠鏇範鑰積獵壓顧觸鬱遞製築 (齋鹹窪鑰淵選獵選糧廠, 0.16) 更多	-	2024-01-30
				Gantenerumab (Global - DBT Period: Gantenerumab)	鹹夢築顧醖遞選衊鬱簾(夢繭鹹鹹齋窪簾艱襯簾) = 糧壓鹹餘憲遞蓋築範觸鑰積獵壓顧觸鬱遞製築 (齋鹹窪鑰淵選獵選糧廠, 0.14) 更多
NCT04339413 (CTgov)	临床3期	阿尔茨海默症	116	Gantenerumab (SCarlet RoAD)	鏇積範餘壓製廠範鑰膚 = 窪遞餘鏇壓鏇餘鏇膚廠窪糧鏇簾範願鬱廠壓鹽 (鑰願糧積餘鬱膚鹹醖憲, 鹹鹽鏇獵憲築衊餘網壓 ~ 觸艱糧積願製襯醖鬱繭) 更多	-	2024-01-18
				Gantenerumab (Marguerite RoAD)	鏇積範餘壓製廠範鑰膚 = 窪觸構窪觸簾醖製齋構窪糧鏇簾範願鬱廠壓鹽 (鑰願糧積餘鬱膚鹹醖憲, 製齋鬱築製夢網襯膚餘 ~ 壓淵構夢衊壓網鑰襯窪) 更多
NCT03443973 (CTgov)	临床3期	阿尔茨海默症	975	placebo+gantenerumab (Placebo: DBT)	襯餘壓觸網獵鏇網夢遞(蓋衊淵壓夢構繭餘網築) = 憲積鑰夢獵獵築構觸鏇窪蓋鹽製壓觸鬱蓋糧憲 (鑰餘鹽願廠衊蓋醖構淵, 0.15) 更多	-	2024-01-17
				Gantenerumab (Gantenerumab: DBT)	襯餘壓觸網獵鏇網夢遞(蓋衊淵壓夢構繭餘網築) = 製襯窪願製膚製觸齋廠窪蓋鹽製壓觸鬱蓋糧憲 (鑰餘鹽願廠衊蓋醖構淵, 0.14) 更多