Alterity Therapeutics Announces Regulatory Clearance to Proceed with Phase 2 Clinical Trial of ATH434 in the UK

Melbourne, Australia, April 27, 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 that the United Kingdom Medicines & Healthcare Products Regulatory Agency (MHRA) has accepted Alterity’s Clinical Trial Authorization Application (CTA) to conduct its Phase 2 clinical trial for ATH434 in Multiple System Atrophy (MSA) ), a rare and very debilitating parkinsonian disease.

“Approval by the MHRA in the UK is another important milestone for our ATH434 clinical development program,” said david stamler, MD, Chairman and CEO, Alterity. “We plan to open our first Phase 2 clinical trial site in New Zealand this quarter and then expand the trial globally to the UK, other European countries, Australia and United States. We look forward to bringing this potential therapy to people with MSA who currently have no treatment to treat the underlying pathology of their disease.”

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 imaging and protein biomarkers such as α-synuclein aggregation and excess iron, which are important contributors to MSA pathology. Clinical parameters and other biomarkers will allow for a comprehensive evaluation of ATH434 efficacy as well as characterization of safety and pharmacokinetics. 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.

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 a Phase 1 clinical trial demonstrating that the agent is well tolerated, orally bioavailable, and reaches brain levels comparable to effective levels in animal models of MSA, with the goal of restoring function in patients with MSA and other parkinsonian disorders.

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 progression

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]

^[1]National 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.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has attempted to identify these forward-looking statements by using terms such as that “expects”, “intends”, “hopes”, “anticipates”, “believes”, “could”, “can”, “evidences” and “estimates” 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 these forward-looking statements are described in the sections entitled “Risk Factors” in the Company’s filings with the SEC, including its most recent annual report. on Form 20-F as well as reports on Form 6-K, including but not limited to: statements relating to the Company’s drug development program, including but not limited to , the initiation, progress and results of clinical trials of the Company’s drug development program, including but not limited to ATH434, and any other statements that are not historical facts. These statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays in the financing, development, testing, regulatory approval, production and commercialization of Company’s drug components, including but not limited to ATH434, uncertainties related to the impact of the novel coronavirus (COVID-19) pandemic on the company’s business, operations and employees, the company’s ability to secure additional future sources of funding, unexpected adverse side effects, or inadequate therapeutic efficacy of drug compounds, including but not limited to ATH434, which could slow or prevent the bringing products to market, the uncertainty of obtaining patent protection for the Company’s intellectual property or trade secrets, the uncertainty of enforcing c success of the Company’s patent rights and the uncertainty of the Company’s freedom to operate.

Any forward-looking statement we make in this press release is based solely on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update publicly any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE Alterity Therapeutics Limited