NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA)..

纽约，2023年11月20日（GLOBE NEWSWIRE）-Anavex生命科学公司（“Anavex”或“公司”）（纳斯达克股票代码：AVXL），一家开发用于治疗神经退行性疾病的分化疗法的临床阶段生物制药公司和神经发育障碍今天宣布，Anavex的代表会见了欧洲药品管理局（EMA）的团队成员。。

These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

这些会议讨论了阿尔茨海默病和Anavex's blarcamesine（Anavex®2-73）阿尔茨海默病临床项目结果的衰弱病理学，包括Anavex®2-73-AD-004研究中获得的数据。

Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease..

根据会议的讨论，Anavex启动了向EMA提交上市许可申请的程序，同时提交了集中程序请求，目的是授权允许直接进入欧盟市场口服blarcamesine治疗阿尔茨海默病。。

Anavex’s goal is to take care of patients in a patient-centric way with the preference for convenient oral treatment options for Alzheimer’s disease not requiring complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.

Anavex的目标是以患者为中心的方式照顾患者，优先选择方便的阿尔茨海默病口服治疗方案，不需要复杂的物流资源，并增加药物管理人员和监测脑水肿和脑出血。

Severe symptoms in relation to Amyloid-Related Imaging Abnormalities (ARIA) is a known risk factor for Alzheimer’s patients taking the class of drugs called monoclonal antibodies, and requires constant and repeated MRI examination, for which not all regions in Europe are currently sufficiently prepared and equipped for in addition to the requirement to address affordability and inequalities in patient access within European Union countries.1,2.

与淀粉样蛋白相关的影像学异常（ARIA）相关的严重症状是阿尔茨海默病患者服用一类称为单克隆抗体的药物的已知危险因素，需要持续和重复的MRI检查，除了要求解决欧盟国家患者接入的负担能力和不平等问题之外，欧洲并非所有地区都有足够的准备和装备.1,2。

“We look forward to working together with the team from EMA,” said David Goldberger, RPh, MLS, Senior Vice President Regulatory Affairs at Anavex. “We continue to work towards fulfilling our purpose of improving patients' lives with oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.”.

“我们期待与EMA的团队合作，”Anavex高级副总裁监管事务部RPh的David Goldberger说。“我们继续努力实现口服布拉卡明改善患者生活的目的，而不需要任何复杂的额外程序来治疗阿尔茨海默病患者。”。

There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.3

根据欧洲脑理事会的数据，欧洲估计有700万人患有阿尔茨海默病，预计到2030年这一数字将翻一番

The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.4,5.

世界卫生组织（WHO）估计，2019年欧洲照顾痴呆症患者（包括阿尔茨海默病）的费用为439亿美元，即每人31144美元。其中包括医院护理，药品，诊断，非正式照顾者时间，社区服务和长期护理设施成本。

“There remains an urgent need for convenient once-daily oral treatment options for Alzheimer’s disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making,” said Christopher U Missling, PhD, President and Chief Executive Officer at Anavex..

总统克里斯托弗·密斯林博士（Christopher U Missling）博士说：“仍然迫切需要方便的每日一次的阿尔茨海默病口服治疗方案，Anavex正朝着潜在的方向发展，以病人为中心的简单管理和共同决策的偏好。Anavex首席执行官。。

In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.

除了痴呆症状的显着改善外，布拉卡明还显示出早期阿尔茨海默氏病中淀粉样蛋白的病理聚集减少，以及脑容量减少（一种众所周知的神经变性标志物）。

Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

来自blarcamesine的阿尔茨海默病2b/3期随机临床试验数据将在即将出版的同行评审期刊上发表。

About Anavex Life Sciences Corp.

关于Anavex生命科学公司。

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer.

Anavex生命科学公司（纳斯达克股票代码：AVXL）是一家上市的生物制药公司，致力于开发用于治疗神经退行性疾病和神经发育障碍的新疗法，包括阿尔茨海默病，帕金森病，瑞特综合征和其他中枢神经系统（CNS））疾病，疼痛和各种类型的癌症。

Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors.

Anavex的主要候选药物Anavex®2-73（blarcamesine）已成功完成阿尔茨海默病的2a期和2b/3期临床试验，这是帕金森病痴呆的2期概念验证研究，以及成人Rett综合征患者的2期和3期研究。ANAVEX®2-73是一种口服候选药物，可通过靶向σ-1和毒蕈碱受体恢复细胞稳态。

Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy.

临床前研究表明其有可能阻止和/或逆转阿尔茨海默病的病程。ANAVEX®2-73还在动物模型中表现出抗惊厥，抗遗忘，神经保护和抗抑郁特性，表明其有可能治疗其他中枢神经系统疾病，包括癫痫。

The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies.

Michael J.Fox帕金森研究基金会之前授予Anavex一项研究补助金，该研究补助金完全资助了开发Anavex®2-73治疗帕金森病的临床前研究。靶向σ-1和M1毒蕈碱受体的ANAVEX®3-71是一种有前途的临床阶段候选药物，显示转基因（3xTg-AD）小鼠中阿尔茨海默病主要标志的疾病改善活性，包括认知缺陷，淀粉样蛋白，和tau病理。

In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company .

在临床前试验中，ANAVEX®3-71已显示出对线粒体功能障碍和神经炎症的有益作用。有关更多信息，请访问www.anavex.com。您还可以与公司联系。

Forward-Looking Statements

前瞻性声明

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC.

本新闻稿中并非严格具有历史意义的陈述是前瞻性陈述。这些陈述只是基于当前信息和期望的预测，涉及许多风险和不确定性。由于各种因素，实际事件或结果可能与任何此类声明中预测的事件或结果有很大差异，包括公司向SEC提交的最新年度报告（表格10-K）中规定的风险。

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof..

提醒读者不要过分依赖这些前瞻性声明，这些声明仅在本声明发布之日起生效。所有前瞻性声明均受本警示声明的整体约束，Anavex Life Sciences Corp.不承担修改或更新本新闻稿的义务，以反映本协议签署之日以后的事件或情况。。

For Further Information:

欲了解更多信息：

Anavex Life Sciences Corp.

Anavex生命科学公司。

Research & Business Development

研究与商业发展

Toll-free: 1-844-689-3939

免费收费：1-844-689-3939

Email: info@anavex.com

电子邮件：info@anavex.com

Investors:

投资者：

Andrew J. Barwicki

Andrew J.Barwicki

Investor Relations

投资者关系

Tel: 516-662-9461

电话：516-662-9461

Email: andrew@barwicki.com

电子邮件：andrew@barwicki.com

1 Frölich L, Jessen F. Editorial: Lecanemab: Appropriate Use Recommendations - A Commentary from a European Perspective. J Prev Alzheimers Dis. 2023;10(3):357-358. doi: 10.14283/jpad.2023.44. PMID: 37357274.

1FrölichL，Jessen F.编辑：Lecanemab：适当的使用建议-欧洲视角的评论。J Prev Alzheimers Dis。2023;10（3）：357-358。doi:10.14283/jpad.2023.44。结论：37357274。

2 Jönsson L, Wimo A, Handels R, Johansson G, Boada M, Engelborghs S, Frölich L, Jessen F, Kehoe PG, Kramberger M, de Mendonςa A, Ousset PJ, Scarmeas N, Visser PJ, Waldemar G, Winblad B. The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer's disease: an EADC-EC viewpoint. Lancet Reg Health Eur.

2JönssonL，Wimo A，Handels R，Johansson G，Boada M，Engelborghs S，FrölichL，Jessen F，Kehoe PG，Kramberger M，deMendonςaA，Ousset PJ，Scarmeas N，Visser PJ，Waldemar G，Winblad B.负担能力lecanemab，一种针对阿尔茨海默病的淀粉样蛋白靶向治疗：EADC-EC观点。柳叶刀Reg Health Eur。

2023 May 22;29:100657. doi: 10.1016/j.lanepe.2023.100657. PMID: 37251789; PMCID: PMC10220264..

2023年5月22日；29:100657.doi:10.1016/j.lanipe.2023.100657。PMID:37251789；PMCID:PMC10220264。。

3 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

三https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

4 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.

4 JönssonL.欧洲痴呆症的个人经济负担。Lancet Reg Health Eur.2022 7月25日；20： 100472.doi:10.1016/j.lanepe.2022.100472。结论：35910037；PMCID:PMC9326307。

5 World Health Organization (WHO); 2021. Global status report on the public health response to dementia.

5世界卫生组织（WHO）；2021.关于痴呆症公共卫生应对的全球状况报告。