- 01US patent: ATH434 composition; extends to 2045.
- 02IP extends life; Phase 3 in MSA; Parkinson's added.
- 03Lowers brain iron; reduces alpha-synuclein; Phase 2 positives.
The US Patent and Trademark Office has granted a gold standard patent for Alterity Therapeutics’ (ASX: ATH) lead clinical asset ATH434 to treat the underlying pathology of neurodegenerative diseases such as multiple system atrophy (MSA), Parkinson’s disease, and related disorders.
The patent provides commercially significant composition of matter protection for a crystalline structure of the mesylate salt form of ATH434, as well as protection for methods for treating neurological conditions using it.
Composition of matter claims are widely recognised as one of the strongest forms of pharmaceutical patent protection.
Importantly, it blocks other parties from manufacturing or commercialising assets with the same molecular compound.
Long-Term Potential
The new patent extends protection for ATH434 to at least 2045, significantly enhancing its strategic value and long-term commercial potential as Alterity moves towards Phase 3 trial activities in MSA.
It also enables future development opportunities in Parkinson’s disease and other neurodegenerative diseases where iron dysregulation and protein aggregation are implicated.
Alterity chief executive officer Dr David Stamler said the new patent would extend the commercial life and revenue potential of ATH434.
“The granting of this new US composition of matter patent reflects the deliberate execution of our intellectual property strategy and is one of the most critical steps we have taken to protect the innovation behind ATH434,” he said.
“Importantly, Parkinson’s disease is now a viable target indication as our strengthened IP provides the protection needed to justify investment in this major neurodegenerative disorder..”
Restoring Brain Pathology
ATH434 is designed to reduce iron accumulation and inhibit abnormal protein aggregation associated with neurodegeneration.
Pre-clinical models have demonstrated it can reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain.
Positive results from a randomised, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA showed clinically meaningful efficacy, target engagement as indicated by key biomarkers and a favourable safety profile, while data from a second Phase 2 open-label biomarker trial on more advanced MSA reinforced these results.
ATH434 has been previously granted fast track designation by the US Food and Drug Administration and orphan drug designation by the FDA and European Commission for the treatment of MSA.
“We remain dedicated to developing ATH434 as a disease-modifying treatment for these debilitating conditions,” Dr Stamler added.
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