Alterity Therapeutics Ltd Stock Price, News & Analysis

Alterity Therapeutics (NASDAQ: ATHE) has issued a shareholder letter highlighting significant progress in 2024 and upcoming milestones for 2025. The company completed a 12-month, double-blind Phase 2 clinical trial of ATH434 in early-stage Multiple System Atrophy (MSA), with topline data expected in late January or early February.

Preliminary results from their open-label biomarker study in advanced MSA patients showed stable or improved clinical measures after 6-months of ATH434 treatment. The study demonstrated stable iron levels and brain volumes in clinical responders, along with reduced neuronal injury compared to untreated patients.

The company also presented preclinical data showing ATH434's potential in a primate model of Parkinson's disease. Their bioMUSE Natural History study, in collaboration with Vanderbilt University Medical Center, led to developing a novel imaging biomarker for assessing brain volume in MSA-affected regions.

Alterity Therapeutics has announced the completion of the last patient visit in its ATH434-201 Phase 2 clinical trial for early-stage multiple system atrophy (MSA). The trial, which is a randomized, double-blind, placebo-controlled study, evaluates ATH434, a disease-modifying drug candidate targeting alpha-synuclein and iron in Parkinsonian disorders.

The company expects to report topline results in late January or early February 2025. This milestone marks the beginning of the final phase, which includes database cleaning and locking before the release of results. The study has garnered significant interest from clinical sites, doctors, and patients globally in the pursuit of a treatment that could potentially slow MSA progression.

Alterity Therapeutics (NASDAQ: ATHE) has appointed Abby Macnish Niven as Company Secretary, following her recent appointment as Chief Financial Officer on September 30, 2024. She succeeds Phillip Hains in the secretary role effective November 18, 2024. Macnish Niven brings extensive experience in private wealth management from ANZ, UBS, and Ord Minett, and consults on governance, finance, and corporate structure. She holds Bachelor degrees in Commerce and Science from the University of Western Australia and is a Chartered Finance Analyst. In this role, she will be responsible for communications between Alterity and ASX.

Alterity Therapeutics presented data from their bioMUSE natural history study at the 35th International Symposium on the Autonomic Nervous System. The presentation focused on tracking Multiple System Atrophy (MSA) progression using advanced neuroimaging techniques. The study introduced the MSA Atrophy Index (MSA-AI), a composite marker derived from specific brain regions to assess disease progression.

Using machine learning tools and state-of-the-art technology beyond traditional MRI methods, researchers observed significant brain volume reductions over 12 months that correlated with clinical worsening. These methods aim to enhance understanding of MSA progression and support the evaluation of disease-modifying therapies.

Alterity Therapeutics (NASDAQ: ATHE) announced a new publication in Metallomics journal highlighting ATH434's unique mechanism as an iron chaperone for treating neurodegenerative diseases. The study demonstrates how ATH434 targets excess reactive iron, which is implicated in conditions like Friedreich's Ataxia, Parkinson's disease, and multiple system atrophy (MSA). Unlike traditional iron chelators, ATH434 shows lower affinity for ferric iron and reversible binding, allowing it to redistribute excess reactive iron without disrupting normal iron functions or generating harmful free radicals.

Alterity Therapeutics reported Q1 FY25 results with key developments in its ATH434 clinical trials. The company highlighted positive interim data from ATH434-202 Phase 2 trial in advanced MSA patients, suggesting potential disease-modifying effects. The ATH434-201 Phase 2 trial in early-stage MSA remains on track for topline data release in January 2025. Multiple data presentations were made at the International Congress of Parkinson's Disease and Movement Disorders®, showcasing ATH434's potential across various neurological conditions. The company appointed Abby Macnish Niven as CFO and reported a cash balance of A$9.28m as of September 30, 2024, with quarterly operating cash outflows of A$3.31M.

Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE), a biotechnology company focused on neurodegenerative disease treatments, announced that CEO David Stamler, M.D. will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024, at 1:30 p.m. ET (October 18, 2024, at 4:30 a.m. AEDT).

The event will be accessible via a live and archived webcast on Alterity's website under the Investors section: Events and Presentations. The webcast archive will be available for three months.

Alterity Therapeutics (NASDAQ: ATHE) presented new data on ATH434 at the Society for Neuroscience 2024 in Chicago. The poster, titled 'Potent Antioxidant and Mitochondrial-protectant Effects of ATH434, a Novel Inhibitor of α-Synuclein Aggregation with Moderate Iron-binding Affinity,' showcased ATH434's neuroprotective and mitochondrial protectant properties, including reducing lipid damage in two neuronal injury models.

The study, led by Dr. Daniel J. Kosman at SUNY Buffalo, demonstrated ATH434's intrinsic antioxidant activity and its ability to redistribute excess labile iron. These properties suggest potential for treating neurodegenerative diseases like Parkinson's. ATH434 also promoted energy production in mitochondria through a pathway less prone to causing oxidative stress in unstressed cells.

Dr. David Stamler, CEO of Alterity, emphasized the importance of these findings in understanding ATH434's potential as a disease-modifying treatment for neurodegenerative disorders.

Alterity Therapeutics (NASDAQ: ATHE) presented multiple data sets at the International Congress of Parkinson's Disease and Movement Disorders®, highlighting the potential of ATH434 as a disease-modifying therapy for Multiple System Atrophy (MSA). Key findings include:

1. In the ATH434-202 Phase 2 open-label trial, 30% of participants showed stable or improved clinical outcomes.

2. Clinical responders demonstrated stability in brain iron levels and neurofilament light chain (NfL) levels, suggesting potential to slow neurodegeneration.

3. ATH434 exhibited a favorable safety profile with no drug-related serious adverse events.

4. The ATH434-201 randomized, double-blind Phase 2 trial baseline data was presented, focusing on early-stage MSA patients.

5. Preclinical data in Parkinson's disease models showed ATH434 reduced brain iron levels and improved motor performance.

Topline data from ATH434-201 is expected in January 2025, with 12-month data from ATH434-202 later in the year.