ATHE Alterity Therapeutics Limited

1.45
-0.11  -7%
Previous Close 1.56
Open 1.55
52 Week Low 0.28
52 Week High 5.15
Market Cap $32,776,163
Shares 22,604,250
Float 22,604,250
Enterprise Value $29,249,724
Volume 139,692
Av. Daily Volume 115,679
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Drug Pipeline

Drug Stage Notes
ATH434
Multiple System Atrophy (MSA)
Phase 2
Phase 2
Phase 2 trial planned.

Latest News

  1. MELBOURNE, Australia and SAN FRANCISCO, Oct. 26, 2020 /PRNewswire/ -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company") today announced it has commenced enrolling patients with Multiple System Atrophy (MSA) in its bioMUSE Study in the United States.

    BioMUSE is a natural history study that aims to track the progression of patients with MSA, a Parkinsonian disorder without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the US under the direction of Daniel Claassen, MD, Associate Professor of Neurology and Principal Investigator. Natural history studies are important for characterizing disease progression in selected patient populations. The study will provide vital information on early stage MSA patients to optimize the design of Alterity's Phase 2 study in MSA. The study will also inform the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy.

    Alterity's lead compound ATH434 has already successfully completed Phase 1 clinical trial and is advancing toward a Phase 2 clinical trial.

    Dr. Claassen said: "This is an important study to expand our understanding of MSA. We are enrolling early stage patients who stand to gain the most from disease modifying treatments. I look forward to working with Alterity on this project and I hope it can provide the foundation for advancing treatments such as ATH434 into the clinic."

    MSA is a neurodegenerative disease with major sources of disability resulting from motor symptoms characteristic of Parkinson's disease and impaired ability to maintain normal blood pressure, bowel function and bladder control. Current treatment includes medications and lifestyle changes to help manage symptoms, but there is no treatment of the underlying cause and no cure.

    The study is enrolling early stage MSA patients and will track changes in clinical measures and biomarkers for up to one year. Over the course of the study, patients will undergo comprehensive evaluation with detailed neurological examination and clinical rating scales of motor, autonomic and activities-of-daily- living symptoms along with specialized neuroimaging and assessment of protein biomarkers in diverse biological specimens.

    Data from bioMUSE will also be used to inform patient selection in Alterity's upcoming Phase 2 clinical trial of ATH434, its lead clinical candidate for the treatment of MSA. The US FDA has encouraged Alterity to utilize data from the bioMUSE study to aid in the development of efficacy endpoints for the Phase 2 study.

    Vanderbilt University Medical Centre is one of the largest academic medical centres in the southeast US managing more than 2 million patients each year. The School of Medicine's biomedical research program is among the nation's top 10 in terms of National Institutes of Health peer review funding.

    Dr David Stamler, Chief Medical Officer, added: "As we prepare for our Phase 2 study, the data from bioMUSE will provide key information to help us optimize the study design. Starting this study brings us one step closer to finding novel treatments for this devastating condition."

    END

    Authorization & Additional information

    This announcement was authorized by Geoffrey Kempler, Chairman and CEO of Alterity Therapeutics Limited.

    About Alterity Therapeutics Limited and ATH434

    Alterity's lead candidate, ATH434 (formerly PBT434), is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown to reduce abnormal accumulation of α-synuclein and tau proteins in animal models of disease by redistributing labile iron in the brain. In this way, it has potential to treat Parkinson's disease and atypical forms of Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).

    ATH434 has been granted Orphan designation for the treatment of MSA by the US FDA and the European Commission.

    For further information please visit the Company's web site at www.alteritytherapeutics.com.

    About Multiple System Atrophy

    Multiple System Atrophy (MSA) is a rare and rapidly progressive neurological disorder affecting adults. It has no known cause. In addition to presenting with motor symptoms like those in Parkinson's disease, individuals with MSA may also experience loss of ability to coordinate voluntary movements and impaired regulation of involuntary body functions such as blood pressure, bowel and bladder control. Most of these symptoms are not addressed by available drugs for patients with Parkinson's disease. As the condition progresses, daily activities become increasingly difficult and complications such as increased difficulty swallowing, vocal cord paralysis, progressive immobility, and poor balance become more prominent. Symptoms tend to appear after age 50 and rapidly advance, leading to profound disability and death.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.

    Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled "Risk Factors" in the Company's filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434 (formerly PBT434), and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug components, including, but not limited to, ATH434, uncertainties relating to the impact of the novel coronavirus (COVID-19) pandemic on the company's business, operations and employees, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, the intellectual property relating to ATH434.

    Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly updated any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alterity-commences-enrolling-multiple-system-atrophy-patients-in-biomuse-study-301160087.html

    SOURCE Alterity Therapeutics Limited

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  2. MELBOURNE, Australia and SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company") today announced that new clinical and experimental pharmacology data for its lead drug candidate ATH434 (formerly PBT434) has been selected for presentation at the 2020 International Congress of Parkinson's Disease and Movement Disorders (MDS 2020) and the American Neurological Association's 2020 Annual Meeting (ANA 2020).

    New animal data from the laboratory of Dr. Nadia Stefanova, Professor of Translational Neurodegeneration Research at the Medical University of Innsbruck, will be presented at ANA 2020. The new data, from an experiment testing ATH434 in an animal model of Multiple System Atrophy (MSA…

    MELBOURNE, Australia and SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company") today announced that new clinical and experimental pharmacology data for its lead drug candidate ATH434 (formerly PBT434) has been selected for presentation at the 2020 International Congress of Parkinson's Disease and Movement Disorders (MDS 2020) and the American Neurological Association's 2020 Annual Meeting (ANA 2020).

    New animal data from the laboratory of Dr. Nadia Stefanova, Professor of Translational Neurodegeneration Research at the Medical University of Innsbruck, will be presented at ANA 2020. The new data, from an experiment testing ATH434 in an animal model of Multiple System Atrophy (MSA), independently confirm and extend previous findings demonstrating that ATH434 reduces α-synuclein pathology, preserves neurons, and improves motor performance.

    ATH434, which is an orally bioavailable, brain penetrant, small molecule inhibitor of α-synuclein aggregation, is being developed for the treatment of MSA, a Parkinsonian disorder. Alpha-synuclein aggregation is implicated in the pathology of MSA and Parkinson's disease.

    Professor Gregor Wenning, Chair of the Division of Neurobiology at Medical University of Innsbruck and Co-Founding Director of the European MSA Study Group, said: "There is a great need for new treatments of this devastating condition. The exceptional work from Dr. Stefanova's team demonstrates the effectiveness of ATH434 in a disease-predictive animal model. I look forward to the continued progress of ATH434 into patient studies."

    Alterity will also present cardiac safety data from its Phase 1 Study of ATH434, marking the first time such information will be shared with an international group of clinicians and researchers in the field of neurological disorders. The new safety data, which focuses on evaluating electrical activity in the heart as measured by the QT interval, reinforces previous safety findings from the Phase 1 clinical study – namely, that ATH434 was generally well tolerated at all doses and had an adverse event profile comparable to placebo in adult and older adult volunteers. The data to be presented indicates that there is no evidence of cardiac liability at clinically tested doses.

    Alterity's Chief Medical Officer, Dr David Stamler, said: "Drug-induced QT prolongation can pose a significant risk for patients, so a clean bill of health on this safety measure is important as we advance to Phase 2. In searching for new treatments to modify disease progression, we need to develop agents that are as safe as possible."

    When paired with favorable pharmacokinetic and safety data previously reported, the new animal and clinical data support the continued development of ATH434 for MSA. The company announced last month that following discussion with the US Food and Drug Administration, it had established a development pathway for ATH434 in MSA and is intending to pursue a global development strategy.

    Due to global restrictions in the wake of COVID-19, this year both conferences will be held in a virtual format with MDS 2020 being held 12-16th September, and ANA 2020 to be held 4-9th October.

    END

    Authorization & Additional information

    This announcement was authorized by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.

    Cision View original content:http://www.prnewswire.com/news-releases/new-data-independently-confirms-and-extends-laboratory-findings-and-expands-safety-profile-of-ath434-301105196.html

    SOURCE Alterity Therapeutics Limited

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  3. Highlights:

    • FDA provides guidance for ATH434 development pathway
    • Company compliant with minimum NASDAQ price
    • End of period cash balance of $9.2M bolstered by $1.5M following issue of shares on 2 July

    MELBOURNE, Australia and SAN FRANCISCO, July 30, 2020 /PRNewswire/ -- Alterity Therapeutics Limited ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company") releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 July 2020 (Q4 FY20).

    Development pathway for ATH434

    On June 30th, Alterity announced that it had received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple…

    Highlights:

    • FDA provides guidance for ATH434 development pathway
    • Company compliant with minimum NASDAQ price
    • End of period cash balance of $9.2M bolstered by $1.5M following issue of shares on 2 July

    MELBOURNE, Australia and SAN FRANCISCO, July 30, 2020 /PRNewswire/ -- Alterity Therapeutics Limited ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company") releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 July 2020 (Q4 FY20).

    Development pathway for ATH434

    On June 30th, Alterity announced that it had received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple System Atrophy (MSA).

    ATH434 is an orally bioavailable, brain penetrant, small molecule inhibitor of α-synuclein aggregation, and is being developed for the treatment of MSA, a Parkinsonian disorder.  Alpha-synuclein aggregation is implicated in the pathology of MSA and Parkinson's disease.

    The company recently met with the FDA following the successful completion of its Phase 1 clinical trial last year and further data analysis. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.

    Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects of the Company's Phase 2 study design including the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study. 

    In parallel with the US strategy, Alterity is also pursuing a regulatory pathway in Europe and Australia. Given the uncertainty of study conduct and recruitment in the COVID-19 era, and with the need to target sites that are minimally impacted, it is prudent for the Company to be flexible in identifying and recruiting sites around the world and maintaining optionality. Planning is underway to meet with European authorities.

    Corporate update

    The Company's $9.2M cash balance was bolstered by the receipt of $1.5M following the issue of shares as part of the company's previously approved "At the Market or ATM" facility and issued in accordance with ASX Listing Rules 7.1 and 7.1A (enabling share issues up to a maximum of 25% of the issued capital of the company).

    In February the company received notification from the Listing Qualifications Department of Nasdaq advising the Company it was non-compliant with Nasdaq's requirement that listed securities maintain a minimum bid price of $US1.00 per share on NASDAQ as outlined in the Nasdaq Listing Rules. This was resolved naturally through improved trading conditions and company performance, and as the closing bid price exceeded $US1.00 per Approved Depositary Share for at least 10 business days, Nasdaq has confirmed re-compliance.

    In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1. of the Appendix 4C incorporates directors' fees, remuneration and superannuation at commercial rates.

    Authorisation & Additional information

    This announcement was authorised by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.

    About Alterity Therapeutics Limited and ATH434

    Alterity's lead candidate, ATH434 (formerly PBT434), is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown to reduce abnormal accumulation of α-synuclein and tau proteins in animal models of disease by redistributing labile iron in the brain. In this way, it has potential to treat Parkinson's disease and atypical forms of Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).

    ATH434 has been granted Orphan designation for the treatment of MSA by the US FDA and the European Commission.

    For further information please visit the Company's web site at www.alteritytherapeutics.com.

    About Multiple System Atrophy

    Multiple System Atrophy (MSA) is a rare and rapidly progressive neurological disorder affecting adults. It has no known cause. In addition to presenting with motor symptoms like those in Parkinson's disease, individuals with MSA may also experience loss of ability to coordinate voluntary movements and impaired regulation of involuntary body functions such as blood pressure, bowel and bladder control. Most of these symptoms are not addressed by available drugs for patients with Parkinson's disease. As the condition progresses, daily activities become increasingly difficult and complications such as increased difficulty swallowing, vocal cord paralysis, progressive immobility, and poor balance become more prominent. Symptoms tend to appear after age 50 and rapidly advance, leading to profound disability.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.

    Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled "Risk Factors" in the Company's filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434 (formerly PBT434), and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug components, including, but not limited to, ATH434, uncertainties relating to the impact of the novel coronavirus (COVID-19) pandemic on the company's business, operations and employees, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, the intellectual property relating to ATH434.

    Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly updated any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Cision View original content:http://www.prnewswire.com/news-releases/alterity-releases-appendix-4c---q4-fy20-quarterly-cash-flow-report-301103581.html

    SOURCE Alterity Therapeutics Limited

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