Alterity Therapeutics announced it has successfully completed enrolment in its ATH434-201 Phase 2 clinical trial. ATH434-201 is a randomized, double-blind, placebo-controlled study in patients with early-stage multiple system atrophy (MSA) conducted across the U.S., Europe, Australia and New Zealand. The ATH434-201 phase 2 clinical trial is a randomized, double- blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA.

The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. Selected biomarkers, such as brain iron and aggregating -synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. ATH434 has been shown preclinically to reduce -synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain.

As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA.

ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission. Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov) About Alterity Therapeutics LimitedAlterity Therapeutics LimitedAltersity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases.

The Company's lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company has tried to identify such forward-looking statements by use of such words as "ex expects," "intends," "hopes," "ant anticipates," "bel believes," "bel believes," "could," "may," "may," "evidences" and other similar expressions, but these words are not the exclusive means of identifying such statements.

important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections of the study. ATH434-201 will be the first half of 2024.