Melbourne, Australia, December 14, 2021 / PRNewswire / – Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to the development of disease-modifying therapies for neurodegenerative conditions, announced today that the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has authorized Alterity’s Phase 2 clinical trial for ATH434 in multisystem atrophy (MSA), a rare and severely debilitating parkinsonian disease.
“Approval by the New Zealand the health authority to proceed with our phase 2 clinical trial is a significant achievement as it paves the way for the start of the study in the first quarter of next year, ”said David stamler, MD, CEO, Alterity. “ATH434 takes a new approach to treat the underlying pathology of MSA by blocking -synuclein aggregation and restoring iron balance in the brain. We look forward to starting our trial and bringing this potential disease treatment to patients with this devastating disease. ”
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers such as -synuclein aggregation and excess iron, which are important contributors to MSA pathology. The clinical parameters and other biomarkers will allow a complete evaluation of the efficacy of ATH434 as well as a characterization of the safety and pharmacokinetics. Patients will receive treatment for 12 months, which will detect changes in the efficacy parameters in order to optimize the design of a definitive Phase 3 study.
Alterity’s lead candidate, ATH434, is the first in a new generation of small molecules designed to inhibit the aggregation of pathological proteins involved 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 multisystem atrophy (MSA). ATH434 has successfully completed a phase 1 clinical trial demonstrating that the agent is well tolerated, orally bioavailable, and achieves 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 received orphan designation for the treatment of MSA by the US FDA and the European Commission.
About multisystem atrophy
Multisystem atrophy (MSA) is a rare neurodegenerative disease characterized by a combination of symptoms that affect both the autonomic nervous system and movement. Symptoms reflect the gradual loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease which causes profound disability. MSA is a parkinsonian disorder characterized by motor impairment, autonomic instability that affects involuntary functions such as maintaining blood pressure and bladder control, and impaired balance and / or coordination that predisposes at the falls. A pathological feature of MSA is the accumulation of the α-synuclein protein in the supporting cells of the central nervous system and the 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 drugs, there is currently no drug that can slow the progression of the disease and there is no cure. .1
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical-stage biotechnology company dedicated to creating an alternative future for people living with neurodegenerative diseases. The Company’s main asset, ATH434, has the potential to treat various parkinsonian disorders. Alterity also has an extensive drug discovery platform generating patentable chemical compounds to intervene in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, UNITED STATES. For more information, please visit the company’s website at www.alteritytherapeutics.com.
Authorization & Additional Information
This advertisement has been authorized by David stamler, CEO of Alterity Therapeutics Limit.
Cheeky Look at the 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 such forward-looking statements by using such words. that “expects”, “intends”, “hopes”, “anticipates”, “believes”, “could”, “could”, “evidence” and “estimates” and other expressions similar, but these words are not the exclusive means of identifying such statements.
Significant factors that could cause actual results to differ materially from those indicated in these forward-looking statements are described in the sections headed “Risk Factors” in the Company’s filings with the SEC, including its annual report on most recent on Form 20-F as well as as reports on Form 6-K, including, but not limited to: but not limited to: but not limited to ATH434, and any other statements which are not facts historical. Such statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays in funding, development, testing, regulatory approval, production and marketing. the Company’s drug components, including, but not limited to ATH434, uncertainties regarding 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 placing products on the market, the uncertainty of obtaining patent protection for the Company’s intellectual property or trade secrets, the uncertainty of successfully e respect 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 assume no obligation to publicly update any forward-looking statement, whether 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