New data independently confirms and extends laboratory findings and expands safety profile of ATH434

Rhea-AI Summary

Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced new clinical data for its drug candidate ATH434, which will be presented at the 2020 International Congress of Parkinson's Disease and Movement Disorders and the American Neurological Association's Annual Meeting. New animal data confirms ATH434's effectiveness in reducing α-synuclein pathology and preserving neurons in a Multiple System Atrophy model. Additionally, new safety data indicates ATH434 has no significant cardiac liability, supporting its advancement to Phase 2 development after FDA discussions.

Positive

• New clinical data for ATH434 shows effectiveness in reducing α-synuclein pathology in a Multiple System Atrophy model.
• Cardiac safety data indicates no significant cardiac liability, supporting ATH434's advancement to Phase 2 study.
• The company has established a development pathway for ATH434 in MSA following discussions with the FDA.

Negative

• None.

MELBOURNE, Australia and SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company") today announced that new clinical and experimental pharmacology data for its lead drug candidate ATH434 (formerly PBT434) has been selected for presentation at the 2020 International Congress of Parkinson's Disease and Movement Disorders (MDS 2020) and the American Neurological Association's 2020 Annual Meeting (ANA 2020).

New animal data from the laboratory of Dr. Nadia Stefanova, Professor of Translational Neurodegeneration Research at the Medical University of Innsbruck, will be presented at ANA 2020. The new data, from an experiment testing ATH434 in an animal model of Multiple System Atrophy (MSA), independently confirm and extend previous findings demonstrating that ATH434 reduces α-synuclein pathology, preserves neurons, and improves motor performance.

ATH434, which is an orally bioavailable, brain penetrant, small molecule inhibitor of α-synuclein aggregation, is being developed for the treatment of MSA, a Parkinsonian disorder. Alpha-synuclein aggregation is implicated in the pathology of MSA and Parkinson's disease.

Professor Gregor Wenning, Chair of the Division of Neurobiology at Medical University of Innsbruck and Co-Founding Director of the European MSA Study Group, said: "There is a great need for new treatments of this devastating condition. The exceptional work from Dr. Stefanova's team demonstrates the effectiveness of ATH434 in a disease-predictive animal model. I look forward to the continued progress of ATH434 into patient studies."

Alterity will also present cardiac safety data from its Phase 1 Study of ATH434, marking the first time such information will be shared with an international group of clinicians and researchers in the field of neurological disorders. The new safety data, which focuses on evaluating electrical activity in the heart as measured by the QT interval, reinforces previous safety findings from the Phase 1 clinical study – namely, that ATH434 was generally well tolerated at all doses and had an adverse event profile comparable to placebo in adult and older adult volunteers. The data to be presented indicates that there is no evidence of cardiac liability at clinically tested doses.

Alterity's Chief Medical Officer, Dr David Stamler, said: "Drug-induced QT prolongation can pose a significant risk for patients, so a clean bill of health on this safety measure is important as we advance to Phase 2. In searching for new treatments to modify disease progression, we need to develop agents that are as safe as possible."

When paired with favorable pharmacokinetic and safety data previously reported, the new animal and clinical data support the continued development of ATH434 for MSA. The company announced last month that following discussion with the US Food and Drug Administration, it had established a development pathway for ATH434 in MSA and is intending to pursue a global development strategy.

Due to global restrictions in the wake of COVID-19, this year both conferences will be held in a virtual format with MDS 2020 being held 12-16^th September, and ANA 2020 to be held 4-9^th October.

END

Authorization & Additional information

This announcement was authorized by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.

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SOURCE Alterity Therapeutics Limited

FAQ

What is the significance of the new data for ATH434 presented by Alterity Therapeutics?

The new data confirms ATH434's effectiveness in reducing α-synuclein pathology and improving motor performance in Multiple System Atrophy models.

What does the cardiac safety data reveal about ATH434?

The cardiac safety data shows that ATH434 is generally well tolerated with no evidence of cardiac liability at clinically tested doses.

When will the conferences presenting ATH434 data take place?

The MDS 2020 conference is scheduled for September 12-16, 2020, and the ANA 2020 meeting will be held from October 4-9, 2020.

What is the next step for ATH434 after the new safety findings?

Following the positive safety findings, Alterity Therapeutics intends to advance ATH434 into Phase 2 studies.

What pathway has Alterity established for ATH434?

Alterity has established a development pathway for ATH434 in Multiple System Atrophy after discussions with the FDA.