<ul>
<li>预计在 2026 年第一季度公布顶线数据</li>
<li>对 AL001 与市场上销售的碳酸锂产品进行的头对头研究，比较健康受试者的锂血液和脑/脑结构药代动力学</li>
</ul>
, /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (&#34; Alzamend&#34;), 一家专注于开发治疗阿尔茨海默病（&#34; 阿尔茨海默病&#34;）、双相情感障碍（&#34; BD&#34;）、重度抑郁症（&#34; MDD&#34;）和创伤后应激障碍（&#34; PTSD&#34;）的新型生物制药公司，今天宣布完成其 AL001 的第一阶段 II 临床研究的临床部分，该研究在健康人群中进行。
<img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827198/Massachusetts_General_Hospital.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827198/Massachusetts_General_Hospital.jpg"/>
在与马萨诸塞州总医院合作作为临床试验地点的情况下，Alzamend 正在研究 AL001 的独特特性。主要目标是评估 AL001 如何将锂输送到大脑，与市场上销售的锂盐进行比较，评估其在实现更好的治疗效果的同时，尽量减少全身副作用的能力。该临床研究利用了由 Tesla Dynamic Coils BV（&#34; Tesla&#34;）开发的独特工程头线圈。这项独特的技术使得高分辨率的全脑锂成像成为可能，从而能够精确量化特定脑结构中的锂。生成的专有成像数据集将用于建立基础参考，帮助 Alzamend 准确识别 AL001 的最佳疾病特异性靶剂量。这些发现将为计划中的阿尔茨海默病、BD、MDD 和 PTSD 的第二阶段临床试验提供信息，预计这些试验将在明年启动，并确认 AL001 在安全性和有效性方面优于传统的碳酸锂。先前在小鼠中的研究表明，AL001 在保持血锂水平较低的同时实现了更好的脑部摄取，为更安全和更有效的治疗奠定了基础。
通过潜在地消除对锂治疗药物监测（&#34; TDM&#34;）的要求，AL001 可能会改变高风险患者群体的治疗并改善临床结果。锂被广泛认为是管理躁狂发作和 BD 维持治疗的高效一线选择，但其采用受到 TDM 挑战的限制。美国食品药品监督管理局批准的锂盐目前面临狭窄的治疗指数，需频繁进行临床医生监测的血浆锂和血液化学测试，以防止不良反应。通过减少全身暴露，Alzamend 的创新 AL001 配方可能代表了治疗阿尔茨海默病等疾病的范式转变，降低了与传统锂方案常见的肾脏和甲状腺并发症的风险。
&#34;我们 AL001 的第二阶段临床试验的临床部分的完成标志着我们使命中的一个关键里程碑，即提供一种具有更好安全性、优越脑穿透力且无需 TDM 的下一代锂治疗，&#34; Alzamend 首席执行官 Stephan Jackman 表示。&#34;我们对患者和研究人员在本研究中所付出的宝贵时间和奉献表示衷心的感谢。他们的贡献对成功完成该研究至关重要。我们期待在 2026 年第一季度报告顶线数据，并进一步推进这一有前景的潜在治疗的临床开发。&#34;
关于 AL001
AL001 是一种新型锂输送系统，具有提供市场上销售的锂盐的好处，同时减轻或避免目前与锂相关的毒性。Alzamend 完成的 AL001 在阿尔茨海默病患者和健康受试者中的 IIA 多次递增剂量研究的结果确定了一个最大耐受剂量（&#34; MTD&#34;），该剂量由独立的安全审查委员会评估。该 MTD 设计为不太可能需要 TDM，同时提供相对适度但有效的锂剂量。AL001 旨在在大脑中有利地分配锂，从而降低其他身体器官的暴露，并与目前市场上的锂盐相比改善安全性。这可以减轻或消除市场上锂盐的毒性上限过低的缺点，这限制了它们对患者和开处方者的有效性。
关于 Alzamend Neuro
Alzamend Neuro 是一家临床阶段的生物制药公司，专注于开发治疗阿尔茨海默病、BD、MDD 和 PTSD 的新型产品。我们的使命是快速开发和上市安全有效的治疗。我们目前的产品线包括两个新型治疗药物候选者，AL001 - 一种专利的离子共晶技术，通过锂、柳酸盐和 L-脯氨酸的治疗组合输送锂，以及 ALZN002 - 一种专利方法，使用突变肽敏感细胞作为细胞基础的治疗疫苗，旨在通过去除大脑中的β-淀粉样蛋白来恢复患者免疫系统对抗阿尔茨海默病的能力。后者是一种第二代主动免疫方法，旨在减轻已批准的被动免疫市场抗体产品的缺点，特别是通过减少与抗体产品相关的给药频率和成本。我们的两个产品候选者均根据专利独占全球许可从南佛罗里达大学研究基金会获得许可。
前瞻性声明
本新闻稿包含根据《1933 年证券法》第 27A 条和《1934 年证券交易法》第 21E 条修订后的 “前瞻性声明”。这些前瞻性声明通常包括具有预测性质的陈述，并依赖或提及未来事件或条件，包括诸如 “相信”、“计划”、“预期”、“项目”、“估计”、“期望”、“意图”、“战略”、“未来”、“机会”、“可能”、“将”、“应该”、“可以”、“潜在” 或类似表达的词语。非历史事实的陈述即为前瞻性声明。前瞻性声明基于当前的信念和假设，这些信念和假设面临风险和不确定性。前瞻性声明仅在作出时有效，Alzamend 没有义务根据新信息或未来事件公开更新任何前瞻性声明。实际结果可能因各种因素与任何前瞻性声明中包含的内容存在重大差异。有关可能影响 Alzamend 业务和财务结果的更多信息，包括潜在风险因素，已包含在 Alzamend 向美国证券交易委员会提交的文件中。所有文件均可在 www.sec.gov 和 Alzamend 的网站 www.Alzamend.com/上获取。
<img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827190/Tesla_Head_Coil.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827190/Tesla_Head_Coil.jpg"/>
<img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827189/Alzamend_Neuro___Corporate_with_R_mark_10262020_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827189/Alzamend_Neuro___Corporate_with_R_mark_10262020_Logo.jpg"/>
来源：Alzamend Neuro, Inc.

ALZN

Alzamend Neuro 宣布在麻省总医院完成其 AL001 的第二阶段临床试验的临床部分。该研究旨在改善锂的输送到大脑，减少全身副作用。预计在 2026 年第一季度公布初步数据。AL001 可能通过消除对治疗药物监测的需求，改变阿尔茨海默病、双相情感障碍、重度抑郁症和创伤后应激障碍的治疗。试验的成功标志着开发更安全、更有效的锂疗法的重要里程碑

<ul>
<li>Topline data expected in first quarter of 2026</li>
<li>Head-to-head studies of AL001 versus a marketed lithium carbonate product was conducted for comparisons of lithium blood and brain/brain-structurepharmacokinetics in healthy subjects</li>
</ul>
<div class="lb-trans"><ul>
<li>预计在 2026 年第一季度公布顶线数据</li>
<li>对 AL001 与市场上销售的碳酸锂产品进行的头对头研究，比较健康受试者的锂血液和脑/脑结构药代动力学</li>
</ul>
</div>, /PRNewswire/ --Alzamend Neuro, Inc. (Nasdaq: ALZN) (&#34; Alzamend&#34;), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (&#34; Alzheimer's&#34;), bipolar disorder (&#34; BD&#34;), major depressive disorder (&#34; MDD&#34;) and post-traumatic stress disorder (&#34; PTSD&#34;), today announced completion of the clinical portion of its first Phase II clinical study of AL001, in healthy human subjects.
<div class="lb-trans">, /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (&#34; Alzamend&#34;), 一家专注于开发治疗阿尔茨海默病（&#34; 阿尔茨海默病&#34;）、双相情感障碍（&#34; BD&#34;）、重度抑郁症（&#34; MDD&#34;）和创伤后应激障碍（&#34; PTSD&#34;）的新型生物制药公司，今天宣布完成其 AL001 的第一阶段 II 临床研究的临床部分，该研究在健康人群中进行。
</div><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827198/Massachusetts_General_Hospital.jpg" alt="" original-src="https://mma.prnewswire.com/media/2827198/Massachusetts_General_Hospital.jpg"/>
In collaboration with Massachusetts General Hospital as the clinical trial site, Alzamend is investigating the distinctive characteristics of AL001. The primary objective is to assess how AL001 delivers lithium to the brain compared to marketed lithium salts, evaluating its ability to achieve better therapeutic efficacy while minimizing systemic side effects. This clinical study utilized a unique, engineered head coil developed by Tesla Dynamic Coils BV (&#34; Tesla&#34;). This one-of-a-kind technology grants the capability for high-resolution, whole-brain lithium imaging, which allows for the precise quantification of lithium within specific brain structures. The resulting proprietary imaging data sets will be used to establish a foundational reference, helping Alzamend accurately identify the optimal, disease-specific target doses of AL001. These findings will inform the planned Phase II clinical trials in Alzheimer's, BD, MDD, and PTSD, which are all expected to be initiated next year, and confirm that AL001 offers a superior balance of safety and efficacy compared to conventional lithium carbonate. Prior research in mice has demonstrated that AL001 achieves superior brain uptake while keeping blood lithium levels lower, setting the stage for safer and more effective therapies.
<div class="lb-trans">在与马萨诸塞州总医院合作作为临床试验地点的情况下，Alzamend 正在研究 AL001 的独特特性。主要目标是评估 AL001 如何将锂输送到大脑，与市场上销售的锂盐进行比较，评估其在实现更好的治疗效果的同时，尽量减少全身副作用的能力。该临床研究利用了由 Tesla Dynamic Coils BV（&#34; Tesla&#34;）开发的独特工程头线圈。这项独特的技术使得高分辨率的全脑锂成像成为可能，从而能够精确量化特定脑结构中的锂。生成的专有成像数据集将用于建立基础参考，帮助 Alzamend 准确识别 AL001 的最佳疾病特异性靶剂量。这些发现将为计划中的阿尔茨海默病、BD、MDD 和 PTSD 的第二阶段临床试验提供信息，预计这些试验将在明年启动，并确认 AL001 在安全性和有效性方面优于传统的碳酸锂。先前在小鼠中的研究表明，AL001 在保持血锂水平较低的同时实现了更好的脑部摄取，为更安全和更有效的治疗奠定了基础。
</div>By potentially removing the requirement for lithium therapeutic drug monitoring (&#34; TDM&#34;), AL001 could transform treatment for at-risk patient groups and enhance clinical outcomes. Lithium is widely recognized as a highly effective first-line option for managing manic episodes and maintenance in BD, yet its adoption has been limited by TDM challenges. Lithium salts approved by the U.S. Food and Drug Administration currently face a narrow therapeutic index, necessitating frequent clinician-monitored plasma lithium and blood chemistry tests to prevent adverse effects. Through reduced systemic exposure, Alzamend's innovative AL001 formulation may represent a paradigm shift in treating disorders such as Alzheimer's, by lowering the risks of kidney and thyroid complications commonly associated with conventional lithium regimens.
<div class="lb-trans">通过潜在地消除对锂治疗药物监测（&#34; TDM&#34;）的要求，AL001 可能会改变高风险患者群体的治疗并改善临床结果。锂被广泛认为是管理躁狂发作和 BD 维持治疗的高效一线选择，但其采用受到 TDM 挑战的限制。美国食品药品监督管理局批准的锂盐目前面临狭窄的治疗指数，需频繁进行临床医生监测的血浆锂和血液化学测试，以防止不良反应。通过减少全身暴露，Alzamend 的创新 AL001 配方可能代表了治疗阿尔茨海默病等疾病的范式转变，降低了与传统锂方案常见的肾脏和甲状腺并发症的风险。
</div>&#34;The completion of the clinical portion of our Phase II trial of AL001 marks a pivotal milestone in our mission to deliver a next-generation lithium therapy with improved safety, superior brain penetration, and no need for TDM,&#34; said Stephan Jackman, Chief Executive Officer of Alzamend. &#34;We extend our heartfelt gratitude to the patients and investigators for their invaluable time and dedication to this study. Their contributions were essential to its successful completion. We look forward to reporting topline data in the first quarter of 2026 and further advancing clinical development of this promising potential therapeutic.&#34;
<div class="lb-trans">&#34;我们 AL001 的第二阶段临床试验的临床部分的完成标志着我们使命中的一个关键里程碑，即提供一种具有更好安全性、优越脑穿透力且无需 TDM 的下一代锂治疗，&#34; Alzamend 首席执行官 Stephan Jackman 表示。&#34;我们对患者和研究人员在本研究中所付出的宝贵时间和奉献表示衷心的感谢。他们的贡献对成功完成该研究至关重要。我们期待在 2026 年第一季度报告顶线数据，并进一步推进这一有前景的潜在治疗的临床开发。&#34;
</div>About AL001
<div class="lb-trans">关于 AL001
</div>AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend's completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified a maximum tolerated dose (&#34; MTD&#34;), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.
<div class="lb-trans">AL001 是一种新型锂输送系统，具有提供市场上销售的锂盐的好处，同时减轻或避免目前与锂相关的毒性。Alzamend 完成的 AL001 在阿尔茨海默病患者和健康受试者中的 IIA 多次递增剂量研究的结果确定了一个最大耐受剂量（&#34; MTD&#34;），该剂量由独立的安全审查委员会评估。该 MTD 设计为不太可能需要 TDM，同时提供相对适度但有效的锂剂量。AL001 旨在在大脑中有利地分配锂，从而降低其他身体器官的暴露，并与目前市场上的锂盐相比改善安全性。这可以减轻或消除市场上锂盐的毒性上限过低的缺点，这限制了它们对患者和开处方者的有效性。
</div>AboutAlzamend Neuro
<div class="lb-trans">关于 Alzamend Neuro
</div>Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
<div class="lb-trans">Alzamend Neuro 是一家临床阶段的生物制药公司，专注于开发治疗阿尔茨海默病、BD、MDD 和 PTSD 的新型产品。我们的使命是快速开发和上市安全有效的治疗。我们目前的产品线包括两个新型治疗药物候选者，AL001 - 一种专利的离子共晶技术，通过锂、柳酸盐和 L-脯氨酸的治疗组合输送锂，以及 ALZN002 - 一种专利方法，使用突变肽敏感细胞作为细胞基础的治疗疫苗，旨在通过去除大脑中的β-淀粉样蛋白来恢复患者免疫系统对抗阿尔茨海默病的能力。后者是一种第二代主动免疫方法，旨在减轻已批准的被动免疫市场抗体产品的缺点，特别是通过减少与抗体产品相关的给药频率和成本。我们的两个产品候选者均根据专利独占全球许可从南佛罗里达大学研究基金会获得许可。
</div>Forward-Looking Statements
<div class="lb-trans">前瞻性声明
</div>This press release contains &#34;forward-looking statements&#34; 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 forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as &#34;believes,&#34; &#34;plans,&#34; &#34;anticipates,&#34; &#34;projects,&#34; &#34;estimates,&#34; &#34;expects,&#34; &#34;intends,&#34; &#34;strategy,&#34; &#34;future,&#34; &#34;opportunity,&#34; &#34;may,&#34; &#34;will,&#34; &#34;should,&#34; &#34;could,&#34; &#34;potential,&#34; or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com/.
<div class="lb-trans">本新闻稿包含根据《1933 年证券法》第 27A 条和《1934 年证券交易法》第 21E 条修订后的 “前瞻性声明”。这些前瞻性声明通常包括具有预测性质的陈述，并依赖或提及未来事件或条件，包括诸如 “相信”、“计划”、“预期”、“项目”、“估计”、“期望”、“意图”、“战略”、“未来”、“机会”、“可能”、“将”、“应该”、“可以”、“潜在” 或类似表达的词语。非历史事实的陈述即为前瞻性声明。前瞻性声明基于当前的信念和假设，这些信念和假设面临风险和不确定性。前瞻性声明仅在作出时有效，Alzamend 没有义务根据新信息或未来事件公开更新任何前瞻性声明。实际结果可能因各种因素与任何前瞻性声明中包含的内容存在重大差异。有关可能影响 Alzamend 业务和财务结果的更多信息，包括潜在风险因素，已包含在 Alzamend 向美国证券交易委员会提交的文件中。所有文件均可在 www.sec.gov 和 Alzamend 的网站 www.Alzamend.com/上获取。
</div><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2827190/Tesla_Head_Coil.jpg" alt="" original-src="https://mma.prnewswire.com/media/2827190/Tesla_Head_Coil.jpg"/>
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SOURCE Alzamend Neuro, Inc.
<div class="lb-trans">来源：Alzamend Neuro, Inc.
</div>

Alzamend Neuro Announces Completion of Clinical Portion of Phase II Clinical Trial of AL001 "Lithium in Brain" Study Conducted at Massachusetts General Hospital | ALZN Stock News

Alzamend Neuro 宣布完成在麻省总医院进行的 AL001“脑内锂” 研究的 II 期临床试验的临床阶段 | ALZN 股票新闻