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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 (ASX: ATH, NASDAQ: ATHE) announced an oral presentation at the American Academy of Neurology conference on April 21, 2021, regarding its lead compound ATH434, aimed at treating Parkinsonian disorders. The presentation showed that ATH434 is neuroprotective, preserving neurons in critical brain regions and improving motor function in an animal model of Multiple System Atrophy (MSA). The findings provide further evidence of ATH434's potential as a disease-modifying treatment, supported by data showing reductions in toxic α-synuclein levels and improved coordination.
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) will present at the 7th International Congress of Multiple System Atrophy (MSA2021) on February 26-27, 2021. This premier virtual event focuses on MSA, a severe neurodegenerative disease without an approved treatment. Alterity will showcase data on ATH434, its lead candidate, highlighting its safety profile concerning blood pressure regulation—a critical factor in MSA. The company is also conducting a natural history study in partnership with Vanderbilt University to support future treatment studies.
Alterity Therapeutics (NASDAQ: ATHE) announced a grant of US$495,000 from The Michael J. Fox Foundation for Parkinson's Research on February 9, 2021. This funding aims to evaluate the pharmacologic profile of ATH434, targeting optimal dosing in future clinical trials for Parkinson's disease. This marks the second grant from the Foundation to support ATH434's development. ATH434 aims to modify alpha-synuclein misfolding, which could impact symptoms of Parkinson's disease and related disorders. The project will utilize primate models to determine dosing in upcoming trials.
Alterity Therapeutics announced the appointment of Dr. David Stamler as CEO, effective immediately. Dr. Stamler, who joined the company in June 2017, has extensive experience in pharmaceutical development, specifically in neurological treatments. He succeeds Geoffrey Kempler, who will transition to Non-Executive Chairman and remain as a consultant. This leadership change coincides with the advancement of Alterity's lead compound, ATH434, into Phase 2 clinical trials. ATH434 has been granted Orphan designation by the US FDA for treating Multiple System Atrophy.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) has secured an exclusive license from UniQuest to develop novel zinc ionophore technology aimed at fighting antimicrobial resistance to superbugs. This technology, which utilizes Alterity's PBT2, allows for the re-sensitization of bacteria to antibiotics, addressing a critical health issue. PBT2 has shown potential in reversing antibiotic resistance in preclinical studies and is patented until 2038. The partnership with UniQuest may significantly enhance Alterity's commercial prospects while maintaining focus on its primary program for ATH434.
Alterity Therapeutics (ATHE) announced the allowance of a new patent by the USPTO, covering over 150 novel compounds aimed at treating neurodegenerative diseases such as Parkinson's and Alzheimer's. This patent grants 20 years of exclusivity, bolstering the company's drug development portfolio. Alterity's lead candidate, ATH434, shows promise in clinical development, demonstrating favorable safety and efficacy in animal models. CEO Geoffrey Kempler emphasized the significance of this patent in pursuing innovative therapeutic options for serious brain diseases.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced the start of patient enrollment for its bioMUSE Study focusing on Multiple System Atrophy (MSA) on Oct. 26, 2020. The study, conducted in collaboration with Vanderbilt University Medical Center, aims to track disease progression in early-stage MSA patients. The bioMUSE study data will inform the upcoming Phase 2 clinical trial of Alterity's lead compound, ATH434, which has completed Phase 1 trials. MSA is a debilitating neurodegenerative condition with no approved therapies, making this study crucial for advancing treatment options.
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.
Alterity Therapeutics Limited (NASDAQ: ATHE) announced positive developments regarding its lead compound ATH434, receiving FDA guidance for its clinical development, including agreement on the Phase 2 study design. The company reported a cash balance of $9.2M, bolstered by an additional $1.5M from a recent share issuance. Furthermore, Alterity has resolved its previous compliance issue with NASDAQ regarding the minimum bid price requirement, confirming re-compliance.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced a successful pre-IND meeting with the FDA regarding its lead compound, ATH434, for treating Multiple System Atrophy (MSA). Following a Phase 1 clinical trial, the FDA provided guidance on the Phase 2 study design, including safety monitoring and patient population. Importantly, there are no approved treatments for MSA, prompting collaboration with the FDA to establish appropriate efficacy endpoints. The company will also conduct a natural history study called bioMUSE to better track disease progression.