Alterity Therapeutics(US:ATHE) Newsfilter·2024-01-22 12:25Core Insights - Alterity Therapeutics is focused on developing disease-modifying treatments for neurodegenerative diseases, particularly Multiple System Atrophy (MSA) and Parkinson's disease, with significant milestones achieved in 2023 and plans for 2024 [1][8]. Company Overview - Alterity Therapeutics is a clinical-stage biotechnology company based in Melbourne, Australia, and San Francisco, California, dedicated to treating neurodegenerative diseases [9]. Clinical Trials - The company is conducting two Phase 2 clinical trials: ATH434-201, which completed participant enrollment in November 2023 and will conclude in November 2024, and ATH434-202, which is assessing more advanced MSA patients and will provide preliminary data in the first half of 2024 [4][5]. - ATH434, the lead candidate, is an orally administered agent that redistributes excess iron in the brain, reduces alpha-synuclein protein, and rescues neuronal function, showing potential to treat both MSA and Parkinson's disease [3][8]. Regulatory Designation - ATH434 has received Orphan Drug Designation (ODD) from the U.S. FDA and the European Commission for the treatment of MSA, which provides benefits such as market exclusivity for 7-10 years, tax credits, and protocol assistance [3]. Research and Development - The bioMUSE Natural History study continues to provide valuable insights into MSA, aiding in the design of ongoing clinical trials and enhancing patient selection [6]. - Promising data from a Parkinson's disease primate model demonstrated that ATH434 can reduce symptoms, which supports the ongoing clinical trials [7]. Future Outlook - 2024 is expected to be pivotal for Alterity, with topline data from the ATH434-201 trial anticipated shortly after its completion in November 2024, and preliminary data from the ATH434-202 trial expected in the first half of the year [8].