Alterity Therapeutics Limited develops treatments for neurodegenerative diseases, with a clinical program centered on Multiple System Atrophy and related Parkinsonian disorders. News about ATHE commonly covers ATH434, its lead MSA candidate, Phase 2 analyses, FDA interactions, chemistry, manufacturing and control updates, and presentations at neurology and imaging conferences.
Coverage also includes bioMUSE Natural History Study biomarker work, including quantitative susceptibility mapping MRI for iron dysregulation in MSA, Appendix 4C cash flow and corporate updates, board appointments, and discussions of the company’s drug discovery platform for patentable chemical compounds targeting neurological disease pathology.
Alterity Therapeutics (NASDAQ: ATHE) announced the allowance of a new composition of matter patent by the USPTO, granting 20 years of exclusivity. This patent covers over 100 novel compounds aimed at treating neurodegenerative diseases, particularly Alzheimer's and Parkinson's. Importantly, the compounds include iron chaperones that address excess iron in the brain, linked to these diseases. CEO David Stamler emphasized this expansion of their intellectual property and the potential of lead asset ATH434 currently in Phase 2 trials.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced a poster presentation from the bioMUSE study at the AAS 2022 Annual Conference held November 2-5, 2022, focusing on urinary symptoms in early Multiple System Atrophy (MSA). This is the first evaluation of urinary symptoms using the Urinary Symptom Profile (USP) in MSA patients. The study involved 16 participants, showing significant urinary issues like urgency and frequency. Alterity's lead candidate, ATH434, aims to treat MSA and has shown promise in preclinical studies, receiving Orphan designation from the U.S. FDA.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announces the dosing of the first patient in its Phase 2 clinical trial for ATH434, aimed at treating Multiple System Atrophy (MSA). The trial has expanded to Europe, Australia, and has received FDA approval to commence in the U.S. As of September 30, 2022, the company reported a cash balance of A$31.9M and an operating cash outflow of A$4.8M, driven by clinical advancement. The randomized trial is set to enroll around 60 patients over 12 months to evaluate efficacy endpoints, enhancing prospects for a future Phase 3 study.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced a poster presentation from its ongoing bioMUSE natural history study at the 147th Annual Meeting of the American Neurological Association on October 24, 2022. The study revealed that deep learning segmentation improves MRI accuracy in assessing brain structures affected by Multiple System Atrophy (MSA). The research involved 21 MSA patients and highlighted significant volume reductions in the brain regions compared to healthy controls. Alterity's lead candidate, ATH434, shows promise in treating neurodegenerative diseases, having completed successful Phase 1 trials.
Alterity Therapeutics has announced the approval of its Phase 2 clinical trial for ATH434 in Australia, targeting Multiple System Atrophy (MSA). The trial aims to assess the efficacy and safety of ATH434 in early-stage MSA patients through a randomized, double-blind, placebo-controlled study. Approximately 60 participants will receive treatment for 12 months, focusing on neuroimaging and protein biomarkers. This trial marks a significant step for Alterity, which has regulatory clearance in five countries for this study.
Alterity Therapeutics announced promising findings from the bioMUSE study at the International Congress of Parkinson's Disease and Movement Disorders. The study involved wearable sensors assessing motor function in Multiple System Atrophy (MSA) patients, showing strong correlation with clinical assessments. Twelve participants wore sensors for up to a year, revealing step count and walking time as sensitive measures of disease progression. These results support the ongoing Phase 2 clinical trial of ATH434, aimed at treating MSA, which will include 60 patients over 12 months.
Alterity Therapeutics has received FDA approval for its Investigational New Drug (IND) application for ATH434, intended for the treatment of Multiple System Atrophy (MSA), a rare neurodegenerative disease. The Phase 2 clinical trial will involve approximately 60 patients and aims to evaluate the efficacy and safety of ATH434 over 12 months. ATH434 has shown promise in preclinical studies, demonstrating the ability to reduce α-synuclein pathology and restoring iron balance in the brain. This milestone opens avenues for advancing treatment options for MSA, which currently lacks disease-modifying therapies.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) has announced the opening of enrollment for its Phase 2 clinical trial of ATH434 for Multiple System Atrophy (MSA) in the UK. This trial aims to assess the treatment's impact on neuroimaging and protein biomarkers, targeting around 60 adult patients. ATH434 has shown promise in preclinical studies, demonstrating the ability to inhibit pathogenic protein aggregation and restore normal iron balance in the brain. MSA affects approximately 15,000 individuals in the U.S., with no current market-approved drugs to slow its progression.
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) has commenced its Phase 2 clinical trial for ATH434 in New Zealand, focusing on Multiple System Atrophy (MSA), a rare Parkinsonian disorder. The regulatory bodies in the U.K. and Italy have granted approval for this trial. The company reported a cash balance of A$34.8 million as of June 30, 2022, with cash outflows of A$4.4 million. Additionally, it received A$4.1 million from the R&D Tax Incentive Scheme, supporting its research and development efforts.
Alterity Therapeutics has announced the dosing of the first patient in its Phase 2 clinical trial of ATH434 for Multiple System Atrophy (MSA), a severe neurodegenerative disease. This trial, which aims to enroll approximately 60 adult patients, is designed to evaluate the safety and efficacy of ATH434 over 12 months. MSA affects about 15,000 individuals in the U.S., and current treatments fail to slow its progression. ATH434 has shown promise in preclinical studies and is the first small molecule designed to target the pathological proteins involved in MSA.