Highlights:
- Participant screening closed for ATH434-201 Phase 2 study
- Independent Data Monitoring Committee recommended the ATH434-201 Phase 2 study continue as planned
- Received
A$4.74M cash refund under the Australian R&DTI Scheme - Data presentations from Alterity’s bioMUSE natural history study of Multiple System Atrophy were delivered at the
International Congress of Parkinson’s Disease and Movement Disorders - New composition of matter patent granted by
European Patent Office - Cash balance on
30 September 2023 ofA$16.7M
“Alterity had a great start to the 2024 financial year with significant developments in the first quarter,” said
“While the ATH434-201 trial is evaluating individuals with early-stage MSA, we are also conducting a second Phase 2 trial in individuals with more advanced disease. This open label, biomarker study will give us the opportunity to assess the effect of ATH434 in multiple populations and we also expect it to provide preliminary data in the first cohort of participants in the first half of next year,” concluded
The Company’s cash position on
Operational Activities
ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in MSA
Today, Alterity announced that screening has closed for its ATH434-201 Phase 2 clinical trial, an important step to completing enrollment in the study. On 26 July, Alterity announced that an independent DMC recommended the trial continue as planned. The DMC conducted a prespecified review of unblinded clinical data from an initial cohort of study participants. The DMC expressed no concerns about safety and recommended that the study continue without modification.
This randomized, double blind, placebo controlled clinical trial continues to progress with early-stage MSA participants enrolled in seven countries globally. The trial has been well received by the study investigators as they implement Alterity’s state of the art methods to diagnose, treat and track the disease.
ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in MSA
The ATH434-202 trial is enrolling according to plan. The study is assessing the effect of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. The primary objective of this study is to evaluate the impact of 12 months treatment with ATH434 on brain iron by MRI in a more advanced patient population than is being studied in Alterity’s double blind Phase 2 trial. Preliminary data from the first cohort in this study is expected in the first half of 2024.
bioMUSE Natural History Study
Alterity’s bioMUSE natural history study continues to produce meaningful data to address the need for novel approaches to the evaluation of individuals with MSA. The diagnosis of early MSA can be challenging as individuals often present similarly to Parkinson’s disease. On 31 August, presentations from bioMUSE were delivered at the prominent
Findings from the bioMUSE study are being incorporated into the Company’s Phase 2 studies. Alterity’s unique protocol designs help to ensure they are enrolling the right patient population with confirmed MSA, thus giving ATH434 the best chance at success. Based on the collaboration with clinical and neuroimaging experts from
Composition of Matter Patent Granted in
The
The composition of matter patent, entitled, “Compounds for and Methods of Treating Diseases”, Patent No. 3938364 covers more than 150 novel pharmaceutical compositions that are designed to redistribute the excess iron implicated in neurodegenerative diseases. The patent will confer on Alterity 20 years of exclusivity over the compounds claimed in the patent, thus providing a strong basis for drug development and commercialization.
About
Authorisation & Additional information
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Investor and Media Contacts:
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+61 4 5064 8064
remy.bernarda@iradvisory.com
+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
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.
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i Dusek, P. et al. Cerebral Iron Deposition in Neurodegeneration. Biomolecules 2022, 12, 714. https://doi.org/10.3390/biom12050714.
Source:
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