Alterity Therapeutics Limited (ATHE) News & EventsATHENews & EventsAlterity Therapeutics Limited

Alterity Therapeutics Granted New Patent for ATH434

Alterity Therapeutics announced that the United States Patent and Trademark Office has granted a new composition of matter patent for ATH434, the company's lead clinical asset. ATH434 is an oral agent designed to treat the underlying pathology of neurodegenerative diseases such as Multiple System Atrophy, Parkinson's disease and related disorders. The newly granted patent represents a significant intellectual property milestone for Alterity and strengthens ATH434's long-term commercial potential as the Company prepares to initiate Phase 3 trial activities in MSA by year-end 2026.

Alterity Therapeutics Receives FDA Meeting Minutes Confirming ATH434 Phase 3 Trial

Alterity Therapeutics announced that it has received the official meeting minutes from its End-of Phase-2 meeting for ATH434 in Multiple System Atrophy from the FDA. The minutes confirm the elements of the registrational Phase 3 program previously announced on June 9 and the path toward a potential new drug application filing. The minutes confirmed that the FDA agreed with the proposed Phase 3 trial design, including the study population, treatment regimen, and efficacy endpoints. Alignment was reached on the selection and analysis of the primary endpoint - the 11-item UMSARS Part I1 rating scale, a functional measure of activities of daily living affected in MSA. Agreement was also reached on selection of key secondary endpoints, including the Swallowing Disturbance Questionnaire, the Orthostatic Hypotension Symptom Assessment and the Clinical Global Impression of Severity. The Phase 3 study is expected to enroll approximately 200 patients who will be randomized in a 1:1 ratio and treated with ATH434 50 mg or matching placebo twice daily for 12 months. The FDA further indicated that a single pivotal trial plus confirmatory evidence could provide the necessary data to support an approval of ATH434 for the treatment of MSA. Alterity expects that the data from its ATH434-201 Phase 2 clinical trial will provide the required confirmatory evidence. The FDA also indicated that the anticipated size of Alterity's safety database at the conclusion for the Phase 3 was reasonable. A single pivotal trial provides an efficient route to completion of the clinical development program and potential filing of an NDA, both in time and resources required. The company also plans to offer an open label extension to participants who complete the Phase 3 trial to continue their treatment and enhance the safety database for ATH434.

Alterity Therapeutics Publishes MSA Study Results

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.