Alterity Therapeutics (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative conditions, announced that the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has authorized Alterity’s Phase 2 clinical trial for ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.
“Approval by the New Zealand health authority to proceed with our Phase 2 clinical trial is a significant achievement as it clears the way to initiate the study in the first quarter of next year,” said David Stamler, M.D., Chief Executive Officer, Alterity. “ATH434 takes a novel approach to treating the underlying pathology of MSA by blocking α-synuclein aggregation and restoring iron balance in the brain. We look forward to starting our trial and bringing this potential disease therapy to patients with this devastating condition.”
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers such as aggregating α-synuclein and excess iron, which are important contributors to MSA pathology. Clinical endpoints and other biomarkers will permit comprehensive assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.
Alterity’s lead candidate, ATH434, is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. In this way, it has excellent potential to treat Parkinson’s disease as well as various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA).