Core Insights - Alterity Therapeutics has announced the completion of the last patient visit in the ATH434-201 Phase 2 trial for early-stage Multiple System Atrophy (MSA), with topline data expected in early 2025 [1][2] Company Overview - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly targeting MSA and other Parkinsonian disorders [1][6] - The lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins associated with neurodegeneration, showing promise in preclinical studies [4][6] Clinical Trial Details - The ATH434-201 Phase 2 trial is a randomized, double-blind, placebo-controlled study involving 77 adults, assessing the efficacy and safety of ATH434 over a 12-month treatment period [3][4] - The trial aims to evaluate neuroimaging and protein biomarkers, including brain iron and α-synuclein, to demonstrate drug activity and clinical efficacy [3][4] Disease Context - Multiple System Atrophy (MSA) is a rare neurodegenerative disease characterized by autonomic nervous system failure and impaired movement, affecting at least 15,000 individuals in the U.S. [5][6] - Currently, there are no approved drugs that can slow the progression of MSA, highlighting the potential significance of ATH434 as a treatment option [5][6]

Core Viewpoint - Alterity Therapeutics has appointed Abby Macnish Niven as Company Secretary following her role as Chief Financial Officer, effective November 18, 2024, succeeding Phillip Hains [1][2]. Group 1: Management Changes - Abby Macnish Niven was appointed as CFO on September 30, 2024, and has extensive experience in private wealth management with firms such as ANZ, UBS, and Ord Minett [3]. - Ms. Macnish Niven will be responsible for communications between the Company and ASX as per ASX Listing Rule 12.6 [4]. Group 2: Company Overview - Alterity Therapeutics is a clinical stage biotechnology company focused on developing treatments for neurodegenerative diseases, with its lead asset ATH434 currently evaluated in two Phase 2 clinical trials for Multiple System Atrophy [5]. - The Company is based in Melbourne, Australia, and San Francisco, California, and has a drug discovery platform aimed at creating patentable compounds for neurological diseases [5].

Core Insights - Alterity Therapeutics presented data from its bioMUSE study on Multiple System Atrophy (MSA) at the 35th International Symposium on the Autonomic Nervous System, focusing on disease progression and neuroimaging advancements [1][2]. Group 1: Company Overview - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly MSA [1][8]. - The company's lead asset, ATH434, is currently being evaluated in two Phase 2 clinical trials for MSA [8]. Group 2: Study Findings - The bioMUSE study aims to track MSA progression and has enrolled approximately 20 individuals with clinically probable or established MSA [4]. - The study utilized advanced neuroimaging techniques, including machine learning, to track brain volume changes in MSA patients, correlating these changes with clinical disease progression [2][3]. - The MSA Atrophy Index (MSA-AI) was introduced as a potential biomarker for assessing MSA progression, derived from specific brain regions affected by the disease [3]. Group 3: Disease Context - MSA is a rare neurodegenerative disease affecting at least 15,000 individuals in the U.S., characterized by autonomic nervous system failure and movement impairment [5]. - Currently, there are no approved therapies to slow MSA progression, highlighting the need for effective disease-modifying treatments [5].

Core Viewpoint - Alterity Therapeutics has announced the publication of significant data regarding the role of iron and iron-targeting agents like ATH434 in treating neurodegenerative diseases, highlighting the potential of ATH434 as a novel therapeutic approach [1][2]. Group 1: Publication Insights - The peer-reviewed journal Metallomics published findings that emphasize the importance of iron-targeting agents in neurodegenerative disease treatment [1]. - The publication titled "ATH434, a promising iron-targeting compound for treating iron regulation disorders" details how ATH434 acts as an iron chaperone, redistributing excess reactive iron to reduce cellular damage [2]. - ATH434 specifically targets the toxic form of iron associated with Friedreich's Ataxia, Parkinson's disease, and Multiple System Atrophy (MSA) [2]. Group 2: ATH434 Characteristics - ATH434 has a lower affinity for ferric iron compared to traditional iron chelators, which are designed to remove stored iron from the body [3]. - The binding of ATH434 is reversible, allowing it to selectively target pathogenic iron without disrupting normal cellular iron functions [3]. - Unlike iron chelators, ATH434 does not promote the conversion of ferrous to ferric iron, thus minimizing the generation of damaging free radicals [3]. Group 3: Clinical Development - ATH434 is currently undergoing two Phase 2 clinical trials: a randomized, double-blind trial for early-stage MSA and an open-label biomarker trial for advanced MSA [5]. - The compound has received Orphan drug designation from the U.S. FDA and the European Commission for the treatment of MSA [5]. - Preclinical studies have shown that ATH434 can reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain [5]. Group 4: Company Overview - Alterity Therapeutics is focused on developing treatments for neurodegenerative diseases and is based in Melbourne, Australia, and San Francisco, California [6]. - The company is dedicated to creating innovative solutions for patients with neurodegenerative conditions, leveraging a broad drug discovery platform [6].

Core Insights - The company is on track to release topline data for the ATH434-201 randomized, double-blind Phase 2 clinical trial in January 2025, which is focused on early-stage Multiple System Atrophy (MSA) [1] - Positive interim data from the ATH434-202 Phase 2 clinical trial indicates that ATH434 may have the potential to modify disease progression in MSA [1][4] - The company appointed Abby Macnish Niven as Chief Financial Officer [1][15] - As of September 30, 2024, the company reported a cash balance of A$9.28 million with operating cash outflows of A$3.31 million for the quarter [1][3] Clinical Trial Updates - Interim results from the ATH434-202 trial suggest that 30% of participants had stable or improved clinical outcomes, indicating a potential disease-modifying effect [6][7] - The average change in Unified MSA Rating Scale Part I (UMSARS I) scores over 6 months was less than that observed in a historical group of untreated MSA patients, suggesting reduced disability [6] - The trial remains ongoing, with topline 12-month results expected in the first half of calendar year 2025 [8] Data Presentations - The company presented multiple data at the International Congress of Parkinson's Disease and Movement Disorders® (MDS), showcasing the potential of ATH434 in various neurological conditions [2][4] - The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months, demonstrating a favorable safety profile with no serious drug-related adverse events [5] Biomarker Insights - The stabilization of iron levels in specific brain regions and stable levels of Neurofilament light chain (NfL) in clinical responders suggest that ATH434 may slow neurodegeneration by modulating brain iron levels [7] - The bioMUSE natural history study continues to provide promising data to track MSA progression and characterize it in terms of various biomarkers [10][11] Corporate Activities - The company engaged in multiple investor activities, including a webinar and a presentation hosted by ShareCafe [16]

Group 1 - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases [1][2] - The company's lead asset, ATH434, is being evaluated in two Phase 2 clinical trials for Multiple System Atrophy, targeting various Parkinsonian disorders [2] - David Stamler, CEO of Alterity, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024 [1] Group 2 - The company is based in Melbourne, Australia, and San Francisco, California, USA [2] - Alterity has a drug discovery platform that generates patentable chemical compounds aimed at treating the underlying pathology of neurological diseases [2] - A live and archived webcast of the CEO's participation in the summit will be available on the company's website for three months [1]

Core Insights - Alterity Therapeutics announced promising new data for ATH434 at the Society for Neuroscience 2024, highlighting its potential in treating neurodegenerative diseases [1][3] - ATH434 demonstrates potent antioxidant and mitochondrial-protectant effects, reducing lipid damage in neuronal injury models [2][3] - The study indicates ATH434's ability to promote energy production in mitochondria and protect against oxidative stress, which is crucial for neurodegenerative disease treatment [3][4] Company Overview - Alterity Therapeutics is focused on developing disease-modifying treatments for neurodegenerative diseases, with ATH434 as its lead candidate [1][5] - ATH434 is designed to inhibit the aggregation of pathological proteins and has shown preclinical efficacy in reducing α-synuclein pathology [4][5] - The company is conducting two Phase 2 clinical trials for ATH434, targeting early-stage and advanced Multiple System Atrophy (MSA) [4][5] Research Findings - The study led by Dr. Daniel J. Kosman demonstrated ATH434's antioxidant properties and its role in cellular energy usage [2][3] - ATH434's mechanisms include reducing oxidative stress and redistributing excess labile iron, which may slow disease progression [3][4] - The research utilized menadione and hemin-induced models to assess ATH434's efficacy as a lipid peroxidation protectant [3][4]

- ATH434 shows promise as a disease-modifying therapy for MSA - - ATH434-202 Phase 2 interim data demonstrate stabilization of clinical symptoms and biomarkers in clinical responders - MELBOURNE, Australia and SAN FRANCISCO, Oct. 02, 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 multiple oral and poster presentations were p ...

MELBOURNE, Australia and SAN FRANCISCO, Sept. 30, 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, announced the appointment of Abby Macnish Niven as the Company’s Chief Financial Officer (CFO), effective today. “We look forward to Abby’s contributions whose broad experience and financial background will help us advance our programs. I would also ...

6-K 1 ea0216061-6k_alterity.htm REPORT OF FOREIGN PRIVATE ISSUER SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-163 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FORM 6-K For the month of September 2024 Alterity Therapeutics Limited (Name of Registrant) Level 14, 350 Collins Street, Melbourne, Victoria 3000 Australia (Address of Principal Executive Office) Indicate by check mark whether the registrant files or will file annual reports un ...