Alterity Therapeutics Limited

Alterity Therapeutics Limited is a biotechnology company focused on developing therapies for neurodegenerative diseases. The company was incorporated in Australia on November 11, 1997, initially as Prana Biotechnology Limited, and changed its name to Alterity Therapeutics Limited on April 8, 2019. Its primary focus is on creating first-in-class treatments for these conditions. Alterity's lead drug candidate is ATH434, which is designed to prevent the buildup and clumping of α-synuclein, a protein linked to neurodegeneration. Preclinical studies have shown ATH434 can redistribute excess labile iron in the central nervous system, reduce α-synuclein aggregation, and protect neurons and support cells, potentially stabilizing or improving function. This suggests its potential for treating iron-mediated diseases such as Parkinson's disease and Multiple System Atrophy (MSA), a rare Parkinsonian disorder. ATH434 has received Fast Track designation from the US FDA for MSA, which aims to speed up the development and review of drugs for serious conditions with unmet medical needs. Additionally, both the US FDA and the European Commission have granted Orphan drug designation for ATH434 for MSA. The company has completed two Phase 2 clinical trials for MSA, with topline results reported for the randomized, double-blind, placebo-controlled Phase 2 study. The company's technology is based on extensive research in neurodegenerative disorders.