Alterity Therapeutics Ltd (ATHE)

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Alterity Therapeutics Reports Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s Disease
- ATH434 improved motor performance and general function –

- Webcast to be held this week to discuss new data and recent clinical progress –

MELBOURNE, Australia and SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- 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 promising new data on the effect of ATH434 in a Parkinson’s disease primate model was presented at the Future of Parkinson’s Disease Conference 2023 that took place November 30 – December 3, 2023 in Austin, TX, USA.

The poster, entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”, was presented by Margaret Bradbury, PhD, Vice President of Research and Nonclinical Development at Alterity and collaborators from Vanderbilt University Medical Center and the Florey Institute of Neuroscience in Melbourne. The presentation demonstrated that ATH434 treatment improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. The favorable impact on Parkinson’s symptoms was associated with lower iron levels in the area of pathology. In addition, ATH434 treatment increased levels of synaptophysin, a protein marker that reflects functional connections between neurons.

David Stamler, M.D., Chief Executive Officer of Alterity, commented, “These new data are exciting because we have shown for the first time that ATH434 can reduce Parkinson’s symptoms in a higher order animal – the monkey. Importantly, the improvements in motor skills and general functioning that parallel human parkinsonism were associated with reductions in iron in affected brain regions, validating the approach we are using in our ongoing clinical trials. The data from this study improve our ability to predict clinical outcomes and increases our confidence level in our ongoing Phase 2 clinical trials in Multiple System Atrophy, a parkinsonian disorder with similar underlying pathology to Parkinson’s disease.”

The study compared daily oral doses of ATH434 (3 or 10 mg/kg) versus a vehicle (placebo) for 12-14 weeks after parkinsonian symptoms were evident. Monkeys were assessed with the Parkinson Behavior Rating Scale (PBRS) before, during and after dosing. At Week 12, all evaluable ATH434-treated monkeys (n=5) had stable or improving PBRS scores from Baseline to Week 12 whereas two of three vehicle-treated monkeys did not demonstrate improvement or worsened, as expected from the progressive nature of the Parkinson model. The components of the PBRS scale indicate that ATH434 reduced motor impairment and improved general functions such as posture, balance, activity, and gait. Favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were associated with lower iron in the right substantia nigra. In addition, monkeys with improved scores had higher right dorsal striatal synaptophysin, indicating functional recovery of nerve endings in this critical motor pathway.

The poster presentation can be accessed on the Published Scientific Research section of the Alterity website here.

Webcast details

AUSTRALIA PARTICIPANTS:
Date: Wednesday, 6 December 2023
Time: 9:00 a.m. AEDT (Sydney/Melbourne)


UNITED STATES PARTICIPANTS:
Date: Tuesday, 5 December 2023
Time: 2:00 p.m. Pacific Time
5:00 p.m. Eastern Time
Register for the Zoom webcast:
https://us02web.zoom.us/webinar/register/WN_9Lv1OWMtSSSqdJrRsKRiTA#/registration
Registration is required and dial in details will be sent directly upon registration.

About ATH434

Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce a-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal