FRAMINGHAM, Mass.--(BUSINESS WIRE)--Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and related neurodegenerative disorders, today announced its participation in the Alzheimer’s Association International Conference (AAIC) in Philadelphia, held from July 28 to August 1, 2024..

马萨诸塞州弗雷明汉（商业新闻短讯）--Alzheon，Inc.，一家临床阶段的生物制药公司，为患有阿尔茨海默氏病（AD）和相关神经退行性疾病的患者开发了一系列候选产品和诊断分析，今天宣布参加2024年7月28日至8月1日在费城举行的阿尔茨海默氏病协会国际会议（AAIC）。。

“Our scientific presentations at this year’s AAIC conference demonstrate our commitment to advancing Alzheimer’s research and developing treatments that can transform the standard of care for people living with Alzheimer’s disease,” said Susan Abushakra, MD, Alzheon’s Chief Medical Officer. “Alzheimer’s is devastating to patients and families, and we believe the data we are presenting reinforce the potential of our lead agent ALZ-801/valiltramiprosate as a first-in-class, oral disease modifying therapy that may simplify the patient journey and provide increased access.

阿尔茨海默病首席医疗官苏珊·阿布沙克拉（SusanAbushakra）医学博士说：“我们在今年的AAIC会议上的科学报告表明，我们致力于推进阿尔茨海默病的研究和开发治疗方法，以改变阿尔茨海默病患者的护理标准。”。“阿尔茨海默氏病对患者和家属具有破坏性，我们相信我们提供的数据增强了我们的主要药物ALZ-801/valiltramiprosate作为一流的口腔疾病缓解疗法的潜力，可以简化患者的旅程并提供更多的机会。

In addition to the presentations at AAIC, we look forward to the upcoming topline from our pivotal APOLLOE4 Phase 3 trial later this year. We believe these data may support ALZ-801 as the first oral treatment to slow the progression of Alzheimer’s disease.”.

除了在AAIC上的演讲之外，我们期待着今年晚些时候我们关键的阿波罗4号3期试验即将到来的主题。我们相信这些数据可能支持ALZ-801作为第一种口服治疗来减缓阿尔茨海默病的进展。”。

Alzheon will give four presentations at the conference, which include the following two oral sessions and two posters:

Alzheon将在会议上进行四次演讲，其中包括以下两次口头会议和两张海报：

Late Breaker Podium Presentation: “Phase 3 Trial of Oral Anti-Amyloid Agent ALZ-801/Valiltramiprosate in APOE4/4 Homozygotes with Early Alzheimer’s Disease: Baseline Characteristics and Prevalence of Comorbid Cerebral Amyloid Angiopathy”

晚期破坏性讲台介绍：“口服抗淀粉样蛋白药物ALZ-801/Valiltramiprosate在患有早期阿尔茨海默病的APOE4/4纯合子中的3期试验：共病脑淀粉样血管病的基线特征和患病率”

Presenter: Dr. Aidan Power, Chief Development Officer, Alzheon Inc.

主持人：艾丹·鲍尔博士，Alzheon Inc.首席开发官。

Date and time: Wednesday, July 31, 2024: 8:00 a.m. ET – 8:45 a.m. ET

日期和时间：2024年7月31日星期三：美国东部时间上午8:00–上午8:45

Featured Research Symposium Presentation: “Plasma Biomarkers, Hippocampal Volume and Cognitive Effects of Oral ALZ-801: The Phase 2 Biomarker Study and its Long-Term Extension in APOE4 Carriers with Early Alzheimer’s Disease”

专题研究研讨会报告：“口服ALZ-801的血浆生物标志物，海马体积和认知作用：2期生物标志物研究及其在患有早期阿尔茨海默病的APOE4携带者中的长期扩展”

Presenter: Dr. Susan Abushakra, Chief Medical Officer, Alzheon Inc.

主持人：苏珊·阿布沙克拉博士，阿尔茨海默病公司首席医疗官。

Date and time: Wednesday, July 31, 2024: 9:00 a.m. ET – 10:30 a.m. ET

日期和时间：2024年7月31日星期三：美国东部时间上午9:00–上午10:30

Poster: “Use of External Comparator-Arm from ADNI-1 for the ALZ-801/Valiltramiprosate Phase 2 Study of APOE4 Carriers with Early Alzheimer’s Disease: Regulatory Basis and Statistical Considerations”

海报：“使用ADNI-1的外部比较臂对患有早期阿尔茨海默氏病的APOE4携带者进行ALZ-801/Valiltramiprosate 2期研究：监管基础和统计考虑”

Presenter: Dr. John Hey, Chief Scientific Officer, Alzheon Inc.

主持人：John Hey博士，Alzheon Inc.首席科学官。

Date and time: Monday, July 29, 2024: 7:30 a.m. ET – 4:15 p.m. ET

日期和时间：2024年7月29日星期一：美国东部时间上午7:30–美国东部时间下午4:15

Poster: “Low Incidence of Amyloid Related Imaging Abnormalities over 104 Weeks in a Phase 2 Study of Amyloid Anti-Oligomer Agent ALZ-801 (Valiltramiprosate) in Biomarker Positive APOE4 Carriers with Early Alzheimer’s Disease”

海报：“在患有早期阿尔茨海默病的生物标志物阳性APOE4携带者中，淀粉样蛋白抗寡聚体药物ALZ-801（Valiltramiprosate）的2期研究中，104周内淀粉样蛋白相关成像异常的发生率较低”

Presenter: Dr. Patrick Kesslak, Senior Clinical Research Fellow

主持人：Patrick Kesslak博士，高级临床研究员

Date and time: Tuesday, July 30, 2024: 7:30 a.m. ET – 4:15 p.m. ET

日期和时间：2024年7月30日星期二：美国东部时间上午7:30–美国东部时间下午4:15

About ALZ-801

关于ALZ-801

ALZ-801/valiltramiprosate is a potential first-in-class, investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD.1-4,6,9 ALZ‑801 is designed to block the formation of neurotoxic soluble beta amyloid oligomers implicated in cognitive decline in Alzheimer’s patients.1-4,6,11 In mechanism of action studies, ALZ-801 has fully inhibited the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.6,9,11 ALZ‑801 acts through a novel enveloping molecular mechanism of action to block formation of neurotoxic soluble amyloid oligomers in the human brain11 associated with the onset and progression of cognitive decline in AD patients.1,4,6,7 ALZ-801 received Fast Track designation from the U.S.

。

Food and Drug Administration in 2017 for Alzheimer’s disease. In clinical trials, ALZ-801 has shown potential for robust clinical efficacy and favorable safety results with no increased risk of brain vasogenic edema.2-7,10,12 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), with potential future program expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–7.

。在临床试验中，ALZ-801显示出强大的临床疗效和良好的安全性结果的潜力，而不会增加脑血管源性水肿的风险[2-7,10,12]。ALZ-801的初始3期计划侧重于具有两个载脂蛋白ε4等位基因拷贝（APOE4/4纯合子）的早期AD患者，未来可能会扩展到携带一个APOE4基因拷贝和非携带者的患者的AD治疗和预防[1-7]。

ALZ-801 Phase 2 Biomarker Trial

ALZ-801 2期生物标志物试验

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease (NCT04693520): This ongoing trial was designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer's patients.

ALZ-801在早期阿尔茨海默病APOE4携带者中的生物标志物作用（NCT04693520）：这项正在进行的试验旨在评估265 mg每日两次口服ALZ-801对早期AD患者AD病理生物标志物的影响，这些患者具有APOE4/4或APOE3/4基因型，占阿尔茨海默病患者的65-70%。

The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic profile of ALZ-801 over 104 weeks of treatment (primary endpoint). An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 104 weeks of treatment for a total of 208 weeks..

该试验还包括在104周的治疗（主要终点）中评估ALZ-801的临床疗效，安全性，耐受性和药代动力学特征。正在进行的长期延长试验评估了ALZ-801额外104周的治疗，共208周。。

ALZ-801 APOLLOE4 Phase 3 Trial

ALZ-801阿波罗4号3期试验

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing trial is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer's patients.

ALZ-801在APOE4/4早期阿尔茨海默氏病受试者中的有效性和安全性研究（NCT04770220）：这项正在进行的试验旨在评估265 mg每日两次口服ALZ-801的有效性，安全性，生物标志物和成像效果。在早期AD受试者中，载脂蛋白ε4等位基因（APOE4/4纯合子）有两个拷贝，约占阿尔茨海默氏病患者的15%。

This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $51 million grant from the National Institute on Aging..

这是一项双盲随机试验，比较口服ALZ-801和安慰剂治疗78周。阿波罗4号试验得到了美国国家老龄研究所5100万美元的资助。。

ALZ-801 APOLLOE4 Long Term Extension Trial

ALZ-801阿波罗4号长期延长试验

An ongoing long-term extension of the trial, APOLLOE4-LTE, evaluates ALZ-801 in subjects who complete the core APOLLOE4 study for an additional 52 weeks of treatment for a total of 130 weeks or 2.5 years over the core and LTE study (NCT06304883).

正在进行的长期延长试验APOLOE4-LTE评估了完成核心APOLOE4研究的受试者的ALZ-801，这些受试者在核心和LTE研究（NCT06304883）的基础上再接受52周的治疗，总共130周或2.5年。

About Alzheon

关于阿尔茨海默病

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of neurodegeneration.

Alzheon，Inc.是一家临床阶段的生物制药公司，为患有阿尔茨海默氏病和其他神经退行性疾病的患者开发了广泛的候选产品和诊断分析组合。我们致力于通过直接解决神经退行性疾病的潜在病理学来开发创新药物。

Our lead Alzheimer’s clinical candidate, ALZ-801/valiltramiprosate, is a first-in-class oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that has been observed to fully block the formation of neurotoxic soluble amyloid oligomers in preclinical tests.

我们的主要阿尔茨海默病临床候选药物ALZ-801/valiltramiprosate是3期开发中的一流口服药物，可作为AD的潜在疾病缓解治疗药物。ALZ-801是一种口服小分子，已被观察到可完全阻断临床前试验中神经毒性可溶性淀粉样蛋白寡聚体的形成。

Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients..

我们的临床专业知识和技术平台专注于使用基于个体遗传和生物标志物信息的精准医学方法开发候选药物和诊断分析，以推进对患者产生最大影响的治疗。。

Alzheon Scientific Publications

阿尔茨海默病科学出版物

1 Tolar M, et al: The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences, 2024; 25, 2727.

1 Tolar M等人：阿尔茨海默氏病和其他神经退行性疾病的单一毒素来源使得能够有针对性地进行治疗和预防，国际分子科学杂志，2024；252727页。

2 Hey J, et al: Analysis of Cerebrospinal Fluid, Plasma β‑Amyloid Biomarkers, and Cognition from a 2‑Year Phase 2 Trial Evaluating Oral ALZ‑801/Valiltramiprosate in APOE4 Carriers with Early Alzheimer’s Disease Using Quantitative Systems Pharmacology Model, Drugs 2024.

2 Hey J等人：使用定量系统药理学模型，Drugs 2024评估APOE4携带者早期阿尔茨海默氏病口服ALZ-801/Valiltramiprosate的2年2期临床试验的脑脊液，血浆β-淀粉样蛋白生物标志物和认知分析。

3 Hey J, et al: Effects of Oral ALZ‑801/Valiltramiprosate on Plasma Biomarkers, Brain Hippocampal Volume, and Cognition: Results of 2‑Year Single‑Arm, Open‑Label, Phase 2 Trial in APOE4 Carriers with Early Alzheimer’s Disease, Drugs 2024.

3 Hey J等人：口服ALZ-801/Valiltramiprosate对血浆生物标志物，脑海马体积和认知的影响：APOE4携带者早期阿尔茨海默病2年单臂开放标签2期试验的结果，药物2024。

4 Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences, 2021; 22, 6355.

；226355年。

5 Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia, 2020; 6: e12117.

5 Abushakra S等人：患有早期阿尔茨海默病的APOEε4/ε4纯合子显示海马萎缩加速和皮质变薄，这与认知能力下降有关，阿尔茨海默病和痴呆症，2020；6： e12117。

6 Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy, 2020; 12: 95.

6 Tolar M等人：Aducanumab，Gantenerumab，BAN2401和ALZ-801-阿尔茨海默病的第一波淀粉样蛋白靶向药物，具有近期批准的潜力，阿尔茨海默病研究与治疗，2020；12： 九十五。

7 Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia, 2019; 1-8.

7 Tolar M等人：阿尔茨海默病治疗的前进之路：重新评估淀粉样蛋白级联假说，阿尔茨海默病与痴呆，2019；1-8。

8 Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs, 2018; 32(9): 849-861.

8 Hey JA等人：Tramiprosate及其前药ALZ-801的内源性代谢物的发现和鉴定，其抑制人脑中β-淀粉样蛋白寡聚体的形成，CNS Drugs，2018；。

9 Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics, 2018; 57(3): 315–333.

9 Hey JA等人：ALZ-801的临床药代动力学和安全性，ALZ-801是一种用于治疗阿尔茨海默氏病的新型曲美酯前药，临床药代动力学，2018；57（3）：315-333。

10 Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer’s Disease, 2017; 4(3): 149-156.

10 Abushakra S等人：曲美磷酸在轻度阿尔茨海默病APOE4/4纯合子患者中的临床效果表明疾病修饰潜力，预防阿尔茨海默病杂志，2017；4（3）：149-156。

11 Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, 2017; 31(6): 495-509.

11 Kocis P等人：阐明曲美酯在阿尔茨海默病中的Aβ42抗聚集作用机制：整合分子分析方法，药代动力学和临床数据，CNS Drugs，2017；31（6）：495-509。

12 Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” Journal of Prevention of Alzheimer’s Disease, 2016; 3(4): 219-228.

12 Abushakra S等人：曲美磷酸在阿尔茨海默病中的临床益处与APOE4等位基因数量增加有关：“APOE4基因剂量效应”，预防阿尔茨海默病杂志，2016；3（4）：219-228。