ATLANTA--(BUSINESS WIRE)--Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced receipt of a “Study May Proceed” letter from the U.S.

亚特兰大-（商业线）-Alzamend Neuro，Inc。（纳斯达克股票代码：ALZN）（“Alzamend”），一家临床阶段生物制药公司，专注于开发治疗阿尔茨海默病（“阿尔茨海默氏症”），双相情感障碍（“BD”），重度抑郁症（“MDD”）和创伤后应激障碍（“PTSD”），今天宣布收到美国的“研究可能会继续”的信件。

Food and Drug Administration (“FDA”) for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treatment of patients with MDD..

美国食品药品监督管理局（“FDA”）启动研究AL001-MDD01，这是AL001的IIA期临床研究，用于治疗MDD患者。。

“We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for MDD. Although lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades,” said Stephan Jackman, Chief Executive Officer of Alzamend.

“我们感谢FDA及时做出有利的回应，开始我们对AL001进行MDD的第一阶段IIA临床研究。虽然锂没有FDA批准的MDD抗抑郁药增强指征，但已经开了几十年来为此目的标签，”Alzamend首席执行官Stephan Jackman说。

“If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring ('TDM'), it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD. We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”.

“如果我们能够开发出不需要常规治疗药物监测（'TDM'）的下一代锂产品（AL001），它将构成对目前锂基治疗的重大改进，并对2100万美国人产生积极影响MDD。我们正在推进这一进程，预计第一名患者将在2024年第一季度服药“。

About AL001

关于AL001

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee.

AL001是一种新型锂输送系统，有可能在减轻或避免目前与锂相关的毒性的同时提供市售锂盐的益处。Alzamend最近完成的阿尔茨海默病患者和健康受试者AL001的IIA期多次递增剂量研究结果确定了由独立安全审查委员会评估的最大耐受剂量（“MTD”）。

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 brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts.

这种MTD被设计为不太可能需要TDM，同时以相对适中但有效的剂量提供锂。与目前市售的锂盐相比，AL001被设计为有利地将锂分布在脑中，导致其他身体器官的较低暴露和改善的安全性。

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..

这可以用于减轻或消除市售锂盐毒性的不利上限，这限制了它们对患者和处方者的有用性。。

While a wide variety of medications have been used historically for augmentation of an antidepressant in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials. Alzamend’s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.

虽然历史上已经使用多种药物来增强MDD中的抗抑郁药，但是锂是在多个随机对照试验中已经证明有效的少数药物之一。Alzamend的目标是通过在临床实践中重要地改善锂治疗的利益-风险关系来恢复锂治疗的效用。

Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug’s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application (“NDA”) pathway for FDA approval, which is available to new formulations of an approved drug..

基于最近完成的研究中观察到的有利的AL001安全性概况和药物组成成分的广泛安全性数据，AL001开发计划可能有资格获得FDA批准的505（b）（2）新药申请（“NDA”）途径，该途径可用于已批准药物的新制剂。。

About Major Depressive Disorder

关于重性抑郁障碍

MDD, also known simply as depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Those affected may also occasionally have delusions or hallucinations. Introduced by a group of U.S.

MDD，也称为抑郁症，是一种精神障碍，其特征是至少两周普遍存在情绪低落，自尊心低下，以及对正常愉快活动失去兴趣或乐趣。受影响的人有时也可能有妄想或幻觉。由美国一群人介绍。

clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this symptom cluster under mood disorders in the 1980 version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) and has become widely used since. The diagnosis of MDD is based on the person’s reported experiences and a mental status examination.

临床医生在20世纪70年代中期，该术语在1980年版的精神疾病诊断和统计手册（DSM-III）中被美国精神病学协会用于情绪障碍下的这种症状群，并且自那时以来已被广泛使用。MDD的诊断基于该人报告的经验和精神状态检查。

There is no laboratory test for the disorder, but testing may be done to rule out physical conditions that can cause similar symptoms. The most common time of onset is in a person’s 20s, with females affected about twice as often as males. The course of the disorder varies widely, from a single episode lasting months, to a lifelong disorder with recurrent major depressive episodes.

没有针对该疾病的实验室测试，但可以进行测试以排除可能导致类似症状的身体状况。发病的最常见时间是一个人20多岁，女性患病的频率约为男性的两倍。该疾病的病程差异很大，从持续数月的单次发作到反复发作的重度抑郁发作的终生疾病。

MDD is believed to be caused by a combination of genetic, environmental, and psychological factors, with about 40% of the risk being genetic. Risk factors include a family history of the condition, major life changes, certain medications, chronic health problems, and substance use. It can negatively affect a person’s personal life, work life, or education as well as sleeping, eating habits, and general health.

MDD被认为是由遗传，环境和心理因素共同引起的，约40%的风险是遗传性的。风险因素包括家族病史，主要生活变化，某些药物，慢性健康问题和药物使用。它可能会对一个人的个人生活，工作生活或教育以及睡眠，饮食习惯和一般健康产生负面影响。

According to the World Health Organization, approximately 280 million people (3.8% of the world’s population) in the world suffer from MDD..

根据世界卫生组织的统计，世界上约有2.8亿人（占世界人口的3.8%）患有MDD。。

About Alzamend Neuro

关于Alzamend Neuro

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.

Alzamend Neuro是一家临床阶段的生物制药公司，专注于开发用于治疗阿尔茨海默氏症，BD，MDD和PTSD的新产品。我们的使命是快速开发和销售安全有效的治疗方法。我们目前的管道包括两种新型治疗药物候选药物AL001-一种专利的离子共晶技术，通过锂，水杨酸盐​​和L-脯氨酸的治疗组合提供锂，和ALZN002-一种使用突变肽致敏细胞作为基于细胞的治疗性疫苗的专利方法，旨在恢复患者免疫系统对抗阿尔茨海默氏症的能力。

Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses..

我们的两种候选产品均已获得南佛罗里达大学研究基金会（Inc.）的许可，具体取决于拥有全球独家许可的使用费。。

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 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 “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions.

本新闻稿包含1933年“证券法”第27A条（经修订）和1934年“证券交易所法”第21E条（经修订）含义内的“前瞻性声明”。这些前瞻性陈述通常包括具有预测性并取决于或指代未来事件或条件的陈述，包括“相信”，“计划”，“预期”，“项目”，“估计”，“期望”，“意图”，“策略”，“未来”，“机会”，“可能”，“将会”，“应该”，“可能”，“潜在”或类似的表达方式。

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.

不是历史事实的陈述是前瞻性陈述。前瞻性陈述基于当前受到风险和不确定性影响的信念和假设。前瞻性陈述仅在做出之日才发表，Alzamend不承担根据新信息或未来事件公开更新任何声明的义务。

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.

由于各种因素，实际结果可能与任何前瞻性声明中包含的结果大不相同。Alzamend向美国证券交易委员会提交的文件中包含了更多可能影响Alzamend业务和财务结果的信息，包括潜在风险因素。

All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com..

所有申请均可在www.sec.gov和Alzamend的网站www.Alzamend.com上获得。。