Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is proud to announce that the first participant has been successfully dosed in their Phase 2 clinical trial of ATH434 in the U.S for Multiple System Atrophy (MSA). MSA is an incredibly rare and debilitating Parkinsonian disorder, and Alterity is committed to developing a disease-modifying treatment that could potentially give those affected a new lease on life.
Alterity is delighted to announce the successful dosing of the first patient in its ATH434 Phase 2 clinical trial at Vanderbilt University Medical Center in the U.S. – an area of great importance to the trial. Alterity is incredibly appreciative of the continuous support of the team at Vanderbilt, and is pleased to be working towards providing a potential new treatment option for individuals living with MSA. Recruitment efforts are already well underway in five countries, and Alterity looks forward to the potential outcomes of the Phase 2 trial.
ATH434 Phase 2 clinical trial is a remarkable opportunity to study the effect of the drug in patients with early-stage MSA. This randomized, double-blind, placebo-controlled investigation will measure the effects of ATH434 on neuroimaging and protein biomarkers, as well as clinical endpoints to demonstrate efficacy and safety. Through the use of wearable sensors, motor activities of the participants will also be monitored to assess the efficacy of the drug. Approximately 60 adults will receive either one of two dose levels of ATH434 or placebo, and will receive treatment for 12 months to track changes in efficacy endpoints. This study is poised to be a major breakthrough in the treatment of MSA.
Alterity’s lead candidate, ATH434, is an oral agent with great potential to treat Parkinson’s disease and Multiple System Atrophy (MSA). This innovative agent is designed to inhibit the aggregation of pathological proteins, which are implicated in neurodegeneration and can lead to nerve cell damage. Preclinical studies show that ATH434 can reduce α-synuclein pathology and restore normal iron balance in the brain, potentially preserving nerve cells. ATH434 has successfully completed Phase 1 studies, proving to be well tolerated and achieving brain levels comparable to efficacious levels in animal models of MSA. Currently, the agent is being studied in a Phase 2 clinical trial in patients with early-stage MSA, and has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European Commission.
About Multiple System Atrophy
MSA is a devastating neurodegenerative disorder that affects an estimated 15,000 individuals in the United States. It is characterized by a progressive loss of both motor and autonomic functions, such as impaired balance and coordination, slowed movement, rigidity, and difficulty with involuntary functions, such as blood pressure maintenance and bladder control. Unfortunately, there is no cure or drug that can slow the progression of the disease. Pathologically, MSA is characterized by the accumulation of the protein alpha-synuclein within glia, the support cells of the central nervous system, as well as neuron loss in multiple brain regions. Those living with MSA experience profound disability, making it a heartbreakingly difficult disease to manage.
About Alterity Therapeutics Limited
Alterity Therapeutics is a biotechnology company that is revolutionizing the future of neurodegenerative disease treatment. Their lead asset, ATH434, has the potential to revolutionize the treatment of Parkinsonian disorders, and their broad drug discovery platform is generating patentable compounds to intercede in disease processes. Based in both Melbourne, Australia and San Francisco, California, Alterity Therapeutics is working to create an alternate future for those living with neurodegenerative diseases.