美国食品药品监督管理局接受阿尔茨海默病关键3期研究的最终方案，简化发展途径-动脉网

FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway

irpages2.eqs.com 等信源发布 2025-01-07 21:30

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MALVERN, Pa.

宾夕法尼亚州马尔文。

Jan. 07, 2025

2025年1月7日

(GLOBE NEWSWIRE) -- via IBN –

（环球通讯社）——通过IBN——

Annovis Bio Inc.

安诺维斯生物股份有限公司。

(NYSE: ANVS) ('Annovis' or the 'Company'), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in .

（纽约证券交易所：ANVS）（“Annovis”或“公司”）是一家晚期临床药物平台公司，开创了阿尔茨海默氏病（AD）和帕金森氏病（PD）等神经退行性疾病的转化疗法，今天宣布，FDA已接受关键的3期AD研究的更新方案，该研究计划于年开始。

January 2025

2025年1月

在

October 2024

2024年10月

, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study.

，FDA批准Annovis根据其2/3期数据进行关键的3期AD研究，证明早期AD患者的认知改善。最初的方案设计提出了两项独立的试验：一项为期6个月的症状研究和一项为期18个月的疾病缓解研究。

Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap..

根据修订后的方案，这些研究现在被整合到一个为期6/18个月的试验中，该试验将包括一个为期6个月的数据读数，重点关注症状效应，然后进行另外12个月的评估，以评估buntanetap的疾病改善潜力。。

“This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “With this design, we can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes.

Annovis创始人、总裁兼首席执行官玛丽亚·麦克切奇尼（MariaMaccecchini）博士表示：“这一综合协议将加快开发时间表，同时保持必要的科学严谨性，以推进buntanetap作为AD治疗方法。”。“通过这种设计，我们可以利用6个月的症状数据来潜在地支持新药申请（NDA）提交，同时无缝地继续进行相同的研究，以评估长期的疾病改善结果。

We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need.”.

我们很高兴能采用这种方法，这使我们更接近于为有需要的患者提供新的治疗方法。”。

About

关于

Annovis Bio

生物新闻

Headquartered in

总部位于

Malvern, Pennsylvania

宾夕法尼亚州马尔文

, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit

，Annovis致力于解决AD和PD等疾病中的神经退行性疾病。该公司的创新方法针对多种神经毒性蛋白，旨在恢复大脑功能并提高患者的生活质量。有关更多信息，请访问

www.annovisbio.com

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Investor Alerts

投资者警示

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at

鼓励感兴趣的投资者和股东通过注册电子邮件警报注册新闻稿和行业更新

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. Additionally, we invite you to explore our updated investor website, which provides comprehensive access to company news, financial reports, and other key information.

此外，我们邀请您浏览我们更新的投资者网站，该网站可全面访问公司新闻、财务报告和其他关键信息。

Forward-Looking Statements

前瞻性声明

This press release contains 'forward-looking' statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的“前瞻性”声明。这些声明包括但不限于公司与临床试验相关的计划。前瞻性陈述基于当前的预期和假设，并受到可能导致实际结果与预测结果产生重大差异的风险和不确定性的影响。

Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the .

这些风险和不确定性包括但不限于与患者入组，布坦塔普的有效性以及公司评估布坦塔普疗效，安全性和耐受性的临床试验的时间，有效性和预期结果有关的风险和不确定性。其他风险因素在公司定期提交给的文件中有详细说明。

SEC

证券交易委员会

, including those listed in the 'Risk Factors' section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-

，包括公司年度报告表10-K“风险因素”部分和表10季度报告中列出的风险因素-

Q. All

Q、全部

forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law..

本新闻稿中的前瞻性声明基于截至本新闻稿发布之日公司可获得的信息。除法律要求外，公司明确否认因新信息、未来事件或其他原因而更新或修订其前瞻性声明的任何义务。。

Contact Information

联系方式

Annovis Bio Inc.

安诺维斯生物股份有限公司。

101 Lindenwood Drive

林登伍德大道101号

Suite 225

225套房

Malvern, PA

宾夕法尼亚州马尔文

19355