Alterity Therapeutics Initiates ATH434 Phase 2 Clinical Trial for the Treatment of Patients With Multiple System Atrophy in Europe

Second region now open for registration for rare, rapidly progressive neurodegenerative disease

Melbourne, Australia and SAN FRANCISCO, August 25, 2022 /PRNewswire/ — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease-modifying treatments for neurodegenerative diseases, today announced The company’s Phase 2 clinical trial of ATH434 for the treatment of patients with multiple system atrophy (MSA) is now open for enrollment in the UK.

“Our Phase 2 clinical trial continues to progress as planned with the launch of the UK study for patients with MSA,” said david stamler, MD, Chairman and CEO, Alterity. “In a short time, we have now started recruiting in our second region, and we look forward to expanding our reach over the coming months. As MSA is a rare disease, we are committed to providing access to the trial to eligible patients. worldwide.”

About the ATH434 Phase 2 Clinical Trial

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study of ATH434 in patients with early-stage SMA. The study will explore the effect of ATH434 treatment on neuroimaging and protein biomarkers, such as excess brain iron and α-synuclein aggregation, which are important contributors to MSA pathology. The clinical parameters will allow a full evaluation of the efficacy of ATH434 as well as the characterization of safety and pharmacokinetics. The use of wearable sensors will allow the evaluation of motor parameters that are important in patients with MSA. The study is expected to enroll approximately 60 adult patients to receive one of two dose levels of ATH434 or a placebo. Patients will receive treatment for 12 months, giving them the opportunity to detect changes in efficacy parameters to optimize the design of a definitive phase 3 study. Additional information about the phase trial 2 can be found by ClinicalTrials.gov identifier: NCT05109091.

About ATH434

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 preclinically shown to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. In this way, it has excellent potential for treating Parkinson’s disease as well as various forms of atypical parkinsonism such as multiple system atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating that the agent is well tolerated, orally bioavailable, and reaches brain levels comparable to effective levels in animal models of MSA. ATH434 has been granted orphan designation for the treatment of MSA by the US FDA and the European Commission.

About Multiple System Atrophy

Multiple system atrophy (MSA) is a rare neurodegenerative disease characterized by autonomic nervous system failure and impaired movement. Symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a disease that progresses rapidly and leads to profound disability. SMA is a parkinsonian disorder characterized by a variable combination of slowed movements and/or rigidity, autonomic instability that affects involuntary functions such as maintenance of blood pressure and bladder control, and poor balance. and/or impaired coordination that predispose to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein in glia, central nervous system support cells, and loss of neurons in several regions of the brain. MSA affects approximately 15,000 people in the United States, and although some of the symptoms of MSA can be treated with medication, there is currently no medication that can slow the progression of the disease and there is no cure. .1

1National Institute of Health: Neurological Disorders and Strokes, Multiple System Atrophy Fact Sheet

About Alterity Therapeutics Limited

Alterity Therapeutics is a clinical-stage biotechnology company dedicated to creating an alternative future for people with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intervene in disease processes. The Company is based in Melbourne, Australiaand San Francisco, California, UNITED STATES. For more information, please visit the Company’s website at www.alteritytherapeutics.com.

Authorization and additional information

This announcement has been authorized by david stamlerCEO of Alterity Therapeutics Limited.

SOURCE Alterity Therapeutics

About Antoine L. Cassell

Check Also

Posters emphasize the prevalence and need for prompt treatment of RVO

Posters presented at the annual meeting of the American Academy of Ophthalmology showed that patients …