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Alterity Therapeutics Limited (symbol: ATHE) is a pioneering biopharmaceutical company based in Melbourne, Australia, focused on developing therapeutic drugs for neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, Huntington's disease, and multiple system atrophy. Founded in 1997 and originally known as Prana Biotechnology Limited, the company rebranded to Alterity Therapeutics Limited in April 2019.
The company’s flagship drug candidate, ATH434, has successfully completed Phase I clinical trials and is geared towards treating Parkinson's disease and other associated movement disorders. The drug has shown promise in clinical evaluations to slow disease progression, thus improving the quality of life for patients.
Alterity is also advancing PBT2, another leading drug candidate, originally designed as an antimicrobial agent but repurposed for treating Alzheimer's and Huntington's diseases. PBT2 has garnered attention owing to its potential to tackle the cognitive decline associated with these debilitating conditions.
Alterity Therapeutics is actively engaged in multiple research collaborations and partnerships with academic institutions and pharmaceutical companies to enhance its drug development pipeline. Their multi-faceted approach to addressing neurodegenerative disorders underscores the company's commitment to innovation and patient care.
Recent achievements include a collaborative study titled “A multimodal approach for diagnosis of early Multiple System Atrophy,” presented at the MDS 2023 conference, demonstrating the company's dedication to advancing scientific understanding and treatment methodologies.
Financially, Alterity Therapeutics maintains a stable condition, actively investing in research and development to push forward its clinical programs. The company's strategic initiatives and ongoing projects highlight its pivotal role in the healthcare domain, with a focus on creating significant therapeutic advancements.
For investors and stakeholders, Alterity Therapeutics represents a compelling opportunity in the biopharmaceutical sector, with a clear focus on addressing unmet medical needs through innovative drug discovery and development.
Alterity Therapeutics (NASDAQ: ATHE) announced the opening of enrollment for its Phase 2 clinical trial of ATH434, targeting Multiple System Atrophy (MSA). Conducted at Vanderbilt University, the trial aims to recruit approximately 60 participants to assess ATH434's efficacy as a disease-modifying treatment. This study employs neuroimaging and motor assessments to evaluate treatment impacts over 12 months, marking a significant milestone as the U.S. joins Europe and Asia-Pacific in recruitment efforts. ATH434, an oral agent, is designed to inhibit protein aggregation in neurodegenerative diseases.
Alterity Therapeutics Limited (NASDAQ: ATHE) announced a 1-for-10 reverse split of its American Depository Shares (ADS), effective January 9, 2023. The ADS Ratio will change from 1 ADS representing 60 Ordinary Shares to 1 ADS representing 600 Ordinary Shares. This adjustment aims to help the company regain compliance with NASDAQ's minimum bid price of $1.00 per share by February 23, 2023. No fractional ADSs will be issued; instead, fractional entitlements will be sold, and net proceeds distributed to shareholders. The company's ADS will trade on a split-adjusted basis under a new CUSIP number.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced that CEO David Stamler will participate in the Sachs Associates 6th Annual Neuroscience Innovation Forum on January 8, 2022, during the J.P. Morgan Healthcare Conference. Dr. Stamler will join a panel titled 'New Approaches to Parkinson's and Movement Disorders,' provide a company update, and engage in investor meetings. The forum will address global bio-partnering advancements and scientific developments in neurodegenerative diseases, which includes key areas like neuropsychiatry and digital therapeutics.
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.
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