Continued expansion of ATH434 Phase 2 Clinical Trial with sites open for recruitment in five countries
Participants in the US and Europe received first dose as part of the ATH434 Phase 2 Clinical Trial
Announced independent study demonstrating that ATH434 prevented the onset of motor and non‐motor symptoms in animals with genetically induced Parkinson’s disease
Granted new composition of matter patent and entered into exclusive license agreement for assets targeting Alzheimer’s disease
Presented at Sachs Associates 6th Annual Neuroscience Innovative Forum
Cash balance on 31 March 2023 of A$21.9M
MELBOURNE, Australia and SAN FRANCISCO, May 10, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31st March 2023 (Q3 FY23).
“We continue to make excellent progress with our ATH434 Phase 2 clinical trial in participants with early‐stage Multiple System Atrophy, a rapidly progressing Parkinsonian disorder with no approved treatment,” said David Stamler, M.D., Chief Executive Officer, Alterity. “The Phase 2 trial is gaining momentum with active recruitment in five countries, including the United States. We were pleased that an independent study was published providing further evidence that ATH434 has potential to be neuroprotective in humans.”
The Company’s cash position on 31 March 2023 was A$21.9M with operating cash outflows of A$4M.
ATH434 Phase 2 Clinical Trial
During the quarter, Alterity's Phase 2 clinical trial of ATH434 for the treatment of participants with Multiple System Atrophy (MSA) opened several new clinical trial sites. The trial is now actively recruiting participants in three regions: Europe, Asia‐Pacific and the U.S. as the Company looks to bring a potential new treatment option to individuals living with MSA.
In the US, the Phase 2 clinical trial of ATH434 opened for enrollment and enrolled the first participant at Vanderbilt University Medical Center in Nashville, Tennessee. Vanderbilt University has been an important partner for the clinical development of ATH434 and initiating the trial in the U.S. is a major milestone for Alterity.
Alterity also expanded enrollment in Europe with the dosing of the first participant in Italy. In addition, Alterity received regulatory authority in France and Austria to proceed with the Phase 2 trial.
In an independent study published in the journal Neurotherapeutics during the quarter, it was reported that ATH434 prevented the onset of motor and non‐motor symptoms in animals with genetically induced Parkinson’s disease. The study found that ATH434 prevented the development of motor impairment in older animals that was associated with a reduction in iron levels and preservation of neurons in the substantia nigra, the brain region affected in Parkinson’s. The authors also demonstrated that ATH434 prevented an early non‐motor symptom (loss of smell) in younger mice and rescued it in older mice. These data support other studies indicating that ATH434 has a beneficial effect on the motor and non‐motor symptoms in animal models of PD. The publication provides further evidence that ATH434 has the potential to address the underlying pathology of Parkinson’s disease and related disorders such as MSA.
Intellectual Property and Business Development
Alterity was granted a new composition of matter patent, entitled “Compounds for and methods of treating diseases” (No. 11,603,364). The patent covers more than 100 novel compounds with an acyl hydrazone (AH) structure and provides 20 years of exclusivity. The new patent is a testament to the ongoing success of Alterity’s discovery team as they continue to generate novel small molecules with potential to treat important neurodegenerative diseases.
Alterity also entered into a Licensing Agreement for the new patent and a sub‐licensing agreement for PBT2 to Professor Colin Masters, M.D., A.O., to advance the compounds for the treatment of Alzheimer’s and related diseases. Professor Masters is a preeminent researcher in the field of Alzheimer’s disease whose work has provided the foundation for recently approved disease modifying treatments for Alzheimer’s disease. Under the license agreement, Alterity grants the entire rights to the AH patents as well as an exclusive worldwide license to develop and commercialise both AH and PBT2 in Alzheimer’s disease. In exchange, Alterity is entitled to future royalties of net sales from the assets.
On 9 January 2023, the company effected a ratio change of its American Depository Shares (ADSs) to Ordinary Shares from the previous ratio of 1 ADS representing 60 Ordinary Shares to 1 ADS representing 600 Ordinary Shares and has regained compliance with NASDAQ’s minimum bid price requirement.
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, consulting fees, remuneration and superannuation at commercial rates.
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com.
Authorization & Additional information
This announcement was authorised by David Stamler, CEO of Alterity Therapeutics Limited.
Investor and Media Contacts:
+61 4 5064 8064
+1 (415) 203‐6386
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, 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 obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.
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 update 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.