ATHE News & Events

Alterity Therapeutics announced the publication of a peer-reviewed study in NeuroImage, demonstrating that quantitative susceptibility mapping MRI can detect disease-specific iron accumulation in the brains of patients with Multiple System Atrophy, distinguish MSA from Parkinson's disease, and track clinical disease severity - including in early-stage disease. MSA patients showed significantly higher iron content in the lentiform nucleus - comprising the globus pallidus and putamen - versus both healthy controls and PD, with the most pronounced effect in the globus pallidus. Iron content in the globus pallidus distinguished MSA from PD with moderate-to-good accuracy, with comparable performance in the early-stage subgroup - a setting in which clinical misdiagnosis is common. Higher iron content was significantly correlated with greater overall disease severity on the Unified Multiple System Atrophy Rating Scale, linking the imaging measure directly to patients' functional and motor impairment. In preliminary 12-month analyses of the early-stage bioMUSE cohort, both the magnitude and spatial extent of abnormal iron accumulation increased progressively, paralleling clinical decline. Alterity remains on track to hold its End-of-Phase 2 meeting with the FDA in mid-2026, the next key step toward initiation of a pivotal Phase 3 trial in MSA.

Alterity Therapeutics announced it has received regulatory feedback following a Type C meeting with the FDA regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy. This second Type C Meeting builds on Alterity's recent regulatory interactions with the FDA and represents a further step for the planned Phase 3 trial in MSA. Alterity received written feedback supporting its plans related to the chemistry, manufacturing, and control elements of the program. The first Type C meeting, which was announced in March, related to clinical pharmacology and non-clinical development aspects of the program. "Confirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program," said David Stamler, CEO of Alterity. "The FDA endorsed our plans related to the manufacture and testing of ATH434 for use in our Phase 3 trial and ultimately for commercialization, if approved. We continue to advance ATH434 through the necessary steps to initiate our pivotal development program, and we look forward to finalizing our plans with the FDA at an End-of-Phase 2 meeting that remains on track for mid-year 2026."