MELBOURNE, Australia and SAN FRANCISCO, April 10, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that new data on ATH434 will be presented at the World Orphan Drug Congress USA 2024 taking place April 23-25, 2024 in Boston, MA..

澳大利亚墨尔本和旧金山，2024年4月10日（环球通讯社）--Alterity Therapeutics（ASX:ATH，NASDAQ:ATH）（“Alterity”或“the Company”）是一家致力于开发神经退行性疾病的疾病缓解疗法的生物技术公司，今天宣布，有关ATH434的新数据将于2024年4月23日至25日在马萨诸塞州波士顿举行的2024年美国世界孤儿药大会上公布。。

Title:

标题：

Biophysical Characteristics of ATH434, a Unique Iron-Targeting Drug for Treating Friedreich’s Ataxia

治疗弗里德里希共济失调的独特铁靶向药物ATH434的生物物理特性

Lead Author:

主要作者：

Ashley Pall, Department of Pharmaceutical Sciences, Wayne State University

阿什利·帕尔，韦恩州立大学药物科学系

As previously announced, three posters from the Company’s development pipeline will also be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting taking place April 13-18, 2024, in Denver, Colorado, USA.

如前所述，该公司开发渠道中的三张海报也将于2024年4月13日至18日在美国科罗拉多州丹佛举行的美国神经病学学会（AAN）2024年年会上发布。

Title:

标题：

A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy (MSA)

新型突触核蛋白聚集抑制剂ATH434治疗多系统萎缩（MSA）的2期研究

Lead Author:

主要作者：

David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics

医学博士DavidStamler，Alterity Therapeutics首席执行官

Date/Time:

日期/时间：

Sunday, April 14, from 11:45 a.m. to 12:45 p.m. Mountain Time (U.S.)

4月14日星期日，美国山地时间上午11:45至下午12:45

Title:

标题：

Neurofilament Light Chain and Clinical Progression in Early Multiple System Atrophy

神经丝轻链与早期多系统萎缩的临床进展

Lead Author:

主要作者：

Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center

Daniel O.Claassen，医学博士，硕士，范德比尔特大学医学中心神经病学教授

Date/Time:

日期/时间：

Monday, April 15, from 5:30 p.m. to 6:30 p.m. Mountain Time (U.S.)

4月15日星期一，山地时间下午5:30至6:30（美国）

Title:

标题：

Effects of ATH434, a Clinical-phase Small Molecule with Moderate Affinity for Iron, in a Parkinson's Disease Model in Macaques

对铁具有中等亲和力的临床期小分子ATH434在猕猴帕金森病模型中的作用

Lead Author:

主要作者：

Margaret Bradbury, Vice President, Research and Nonclinical Development, Alterity Therapeutics

Margaret Bradbury，Alterity Therapeutics研究和非临床开发副总裁

Date/Time:

日期/时间：

Tuesday, April 16, from 11:45 a.m. to 12:45 p.m. Mountain Time (U.S.)

4月16日星期二，美国山地时间上午11:45至下午12:45

About ATH434

关于ATH434

Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA).

Alterity的主要候选药物ATH434是一种口服药物，旨在抑制与神经变性有关的病理蛋白的聚集。临床前已证明，ATH434可通过恢复大脑中正常的铁平衡来减少α-突触核蛋白病理并保留神经元功能。作为一种铁伴侣，它具有治疗帕金森病以及多种帕金森病（如多系统萎缩（MSA））的巨大潜力。

ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA.

ATH434成功完成了第一阶段研究，证明该药物具有良好的耐受性，并达到了与MSA动物模型中有效水平相当的大脑水平。ATH434目前正在两项临床试验中进行研究：研究ATH434-201是一项针对早期MSA患者的随机，双盲，安慰剂对照的2期临床试验，研究ATH434-202是一项开放标签的2期生物标志物试验，用于晚期MSA患者。

ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission..

ATH434已被美国FDA和欧盟委员会授予用于治疗MSA的孤儿药名称。。

About ATH434-201 Phase 2 Clinical Trial

关于ATH434-201 2期临床试验

The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics.

ATH434-201 2期临床试验是一项针对早期MSA患者的ATH434的随机，双盲，安慰剂对照研究。该研究将评估ATH434治疗对神经影像学和蛋白质生物标志物的影响，以证明目标参与和临床终点，以证明疗效，此外还将评估安全性和药代动力学。

Selected biomarkers, such as brain iron and aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors have also been employed to evaluate motor activities that are important to patients with MSA. The study enrolled 77 adults who were randomly assigned to receive one of two dose levels of ATH434 or placebo.

选定的生物标志物，例如脑铁和聚集的α-突触核蛋白，是MSA病理学的重要贡献者，因此是证明药物活性的合适靶标。可穿戴传感器也被用于评估对MSA患者很重要的运动活动。该研究招募了77名成年人，他们被随机分配接受两种剂量水平的ATH434或安慰剂中的一种。

Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091..

参与者将接受12个月的治疗，这将提供一个机会来检测疗效终点的变化，以优化最终3期研究的设计。有关2期试验的其他信息，请访问ClinicalTrials.gov标识符：NCT05109091。。

About bioMUSE

关于bioMUSE

Biomarkers of progression in Multiple System Atrophy (bioMUSE) is a natural history study that aims to track the progression of individuals with MSA, a parkinsonian disorder without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under the direction of Daniel Claassen, M.D., M.S., Professor of Neurology and Principal Investigator.

多系统萎缩进展的生物标志物（bioMUSE）是一项自然史研究，旨在追踪MSA患者的进展，MSA是一种未经批准治疗的帕金森病。这项研究是在美国范德比尔特大学医学中心（VanderbiltUniversity Medical Center）的指导下进行的，医学博士丹尼尔·克拉森（DanielClaassen）是神经病学教授兼首席研究员。

Natural history studies are important for characterizing disease progression in selected patient populations. The study has provided rich data for optimizing the design of Alterity’s randomized ATH434-201 Phase 2 clinical trial and enrolled approximately 20 individuals with clinically probable or clinically established MSA.

自然史研究对于表征选定患者人群的疾病进展很重要。该研究为优化Alterity的随机ATH434-201 2期临床试验的设计提供了丰富的数据，并招募了大约20名临床可能或临床确定的MSA患者。

BioMUSE continues to provide vital information on early stage MSA patients, informs the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy, and delivers clinical data to characterize disease progression in a patient population that mirrors those currently enrolling in the Phase 2 clinical trial. .

BioMUSE继续提供有关早期MSA患者的重要信息，告知选择适合评估目标参与和初步疗效的生物标志物，并提供临床数据来表征患者群体中的疾病进展，这反映了目前正在参加2期临床试验的患者群体。。

About Multiple System Atrophy

关于多系统萎缩

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability.

多系统萎缩（MSA）是一种罕见的神经退行性疾病，其特征是自主神经系统衰竭和运动受损。这些症状反映了大脑和脊髓中不同类型神经细胞的功能逐渐丧失和死亡。它是一种快速进展的疾病，会导致严重的残疾。

MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions.

MSA是一种帕金森病，其特征是运动缓慢和/或僵硬，自主神经不稳定（影响血压维持和膀胱控制等非自愿功能）以及平衡和/或协调受损（易跌倒）的可变组合。MSA的病理标志是蛋白质α-突触核蛋白在神经胶质细胞，中枢神经系统的支持细胞中的积累以及多个大脑区域的神经元丢失。

MSA affects at least 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.1.

MSA影响美国至少15000人，虽然MSA的一些症状可以用药物治疗，但目前没有药物能够减缓疾病进展，也无法治愈。

¹Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)

¹多系统萎缩|国家神经疾病和中风研究所（nih.gov）

About Parkinson’s Disease

关于帕金森氏病

Parkinson's disease (PD) is the second most common neurodegenerative disorder and causes unintended or uncontrollable movements of the body along with neuropsychiatric and other nonmotor features. The precise cause of PD is unknown, but some cases are hereditary while others are thought to occur from a combination of genetics and environmental factors that trigger the disease. In PD, brain cells become damaged or die in the substantia nigra, the part of the brain that produces dopamine--a chemical needed to produce smooth, purposeful movement.

帕金森氏病（PD）是第二大最常见的神经退行性疾病，会导致身体意外或无法控制的运动以及神经精神和其他非运动特征。帕金森病的确切病因尚不清楚，但有些病例是遗传性的，而另一些病例被认为是由遗传因素和环境因素共同引发的。在帕金森病中，脑细胞在黑质中受损或死亡，黑质是大脑产生多巴胺的部分，多巴胺是产生平稳、有目的运动所需的化学物质。

The cardinal symptoms of PD are tremors, rigidity, slowing of movements, and later in disease, impaired balance. Other symptoms may include difficulty swallowing, chewing, or speaking; emotional changes; urinary problems or constipation; dementia or other cognitive problems; fatigue; and problems sleeping.2 Nearly one million people in the U.S.

PD的主要症状是震颤，僵硬，运动减慢，后来在疾病中，平衡受损。其他症状可能包括吞咽困难，咀嚼困难或说话困难；情绪变化；泌尿系统问题或便秘；痴呆或其他认知问题；疲劳；和睡眠问题。2美国近100万人。

and more than 10 million people worldwide are living with PD. Approximately 60,000 Americans are diagnosed with PD each year.3.

全世界有1000多万人患有帕金森病。每年约有6万美国人被诊断出患有帕金森病。

¹Beauchamp et al, “ATH434 Rescues Pre‑motor Hyposmia in a Mouse Model of Parkinsonism, Neurotherapeutics, DOI:10.1007/s13311-022-01300-0

¹Beauchamp等人，“ATH434在帕金森病小鼠模型中拯救运动前低渗症，神经治疗学，DOI:10.1007/s13311-022-01300-0

²National Institute of Health: Neurological Disorders and Stroke, Parkinson's Disease Information Page;

²美国国立卫生研究院：神经系统疾病和中风，帕金森病信息页面；

³Parkinson’s Foundation

³帕金森氏基金会

About Alterity Therapeutics Limited

关于Alterity Therapeutics Limited

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy.

Alterity Therapeutics是一家临床阶段生物技术公司，致力于为患有神经退行性疾病的人创造另一个未来。该公司的主要资产ATH434具有治疗各种帕金森病的潜力，目前正在多系统萎缩的两个2期临床试验中进行评估。

Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com..

Alterity还拥有一个广泛的药物发现平台，产生可申请专利的化合物，以治疗神经系统疾病的潜在病理。公司总部位于澳大利亚墨尔本和美国加利福尼亚州旧金山。有关更多信息，请访问公司网站www.alteritytherapeutics.com。。

Authorisation & Additional information

授权和附加信息

This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.

本公告由Alterity Therapeutics Limited首席执行官David Stamler授权。

Investor and Media Contacts:

投资者和媒体联系人：

Australia

澳大利亚

Hannah Howlett

汉娜·霍利特

we-aualteritytherapeutics@we-worldwide.com

we-aualteritytherapeutics@we-worldwide.com

+61 450 648 064

+61 450 648 064

U.S.

U、 S。

Remy Bernarda

雷米·贝尔纳达

remy.bernarda@iradvisory.com

remy.bernarda@iradvisory.com

+1 (415) 203-6386

+1 (415) 203-6386

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 and section21EoftheSecuritiesExchangeActof1934.TheCompanyhastriedtoidentifysuchforward-lookingstatementsbyuse of such words as 'expects,' 'intends,' 'hopes,' 'anticipates,' 'believes,' 'could,' 'may,' 'evidences' and 'estimates,' and other similar expressions, but these words are not the exclusive means of identifying suchstatements..

本新闻稿包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的“前瞻性声明”。公司试图通过“预期”、“意图”、“希望”、“预期”、“相信”、“可能”、“可能”、“证据”和“估计”等词语来识别此类前瞻性声明，但这些词语并不是识别此类声明的唯一手段。。

Importantfactorsthatcouldcauseactualresultstodiffermateriallyfromthoseindicatedbysuchforward-lookingstatements aredescribedinthesectionstitled“RiskFactors”intheCompany’sfilingswiththeSEC,includingitsmostrecentAnnualReport onForm20-FaswellasreportsonForm6-K,including,butnotlimitedtothefollowing:statementsrelatingtotheCompany's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company'sdrugdevelopmentprogram,including,butnotlimitedto,ATH434,andanyotherstatementsthatarenothistorical facts.Suchstatementsinvolverisksanduncertainties,including,butnotlimitedto,thoserisksanduncertaintiesrelatingtothe difficultiesordelaysinfinancing,development,testing,regulatoryapproval,productionandmarketingoftheCompany’sdrug components,including,butnotlimitedto,ATH434,theabilityoftheCompanytoprocureadditionalfuturesourcesoffinancing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limitedto,ATH434,thatcouldslowor prevent productscomingtomarket,the uncertaintyof obtaining patent protectionfortheCompany's intellectualpropertyortradesecrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate..

可能导致结果与这些前瞻性陈述所示结果产生实质性差异的重要因素在公司与SEC的文件中“风险因素”部分进行了描述，包括其最新的20-FASWELLAS Form6-K年度报告，包括但不限于以下内容：关于公司药物开发计划的声明，包括但不限于公司药物开发计划临床试验的启动、进展和结果，包括但不限于ATH434和任何其他声明历史事实。此类陈述涉及风险和不确定性，包括但不限于与公司药物成分的融资、开发、测试、监管批准、生产和营销困难相关的风险和不确定性，包括但不限于ATH434，公司未来的融资能力，意外的不良副作用或公司药物化合物的治疗效果不足，包括但不限于ATH434，这可能会阻止产品进入市场，公司获得专利保护的不确定性知识产权或商业秘密、成功实施公司专利权的不确定性以及公司运营自由的不确定性。。

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaksonlyasofthedateonwhichitismade.Weundertakenoobligationtopubliclyupdateanyforward-lookingstatement, whetherwrittenororal,thatmaybemadefromtimetotime,whetherasaresultofnewinformation,futuredevelopmentsor otherwise..

我们在本新闻稿中所作的任何前瞻性声明均仅基于我们目前可获得的信息，以及我们所发表的声明。我们不准备公开更新任何前瞻性声明，无论是书面的还是书面的，无论是由于新信息、未来发展还是其他原因。。