Company: ATHE
Filing Date: 2025-08-29
Form Type: 20-F
Source: 0001213900-25-082027
Chunk: 47

Company: ALTERITY THERAPEUTICS LTD
Filing Date: 2025-08-29
Form: 20-F
Item: Item 4
Chunk 47
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 and PBT2 in Alzheimer’s disease. In exchange, Alterity is entitled to future royalties of net sales from the assets.

Huntington’s disease

PBT2 was also evaluated as a treatment for Huntington’s disease. Preclinically, PBT2 has demonstrated efficacy in the R6/2 mouse model of Huntington disease. In 2012 a Phase 2 trial to test PBT2 in patients with Huntington disease over six months was undertaken under an U.S. IND application and achieved its primary objective with PBT2 being demonstrated as safe and well tolerated. During 2015 and 2016, three new PBT2 Phase 1 trials were completed providing further safety, pharmacokinetic and pharmacodynamic information on PBT2. In 2015 we reported that the FDA had placed PBT2 on Partial Clinical Hold, based on toxicology findings that limited the dose of PBT2 that could be used in future trials.

Non-neurodegenerative applications

Antibiotic Resistance

In December 2020, Alterity acquired an exclusive world-wide license from UniQuest, the commercialisation company of The University of Queensland (UQ), for the development and commercialisation of novel zinc ionophore technology to combat antimicrobial resistance in superbugs. Under the license, Alterity has the rights to develop and commercialise therapies that re-sensitize bacteria to antibiotics. The licensed technology combines Alterity’s PBT2 and other zinc ionophores with commonly used antibiotics to treat infections caused by multidrug resistant bacteria. A published article in the high-impact journal Science Translational Medicine, showed that PBT2 could reverse antibiotic resistance to critical superbugs and demonstrate efficacy in an animal model of sepsis.

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Clinical Trials for Our Product Candidates

<{self.tag} alt="{self.alt}" src="{self.src}">Our Current Pipeline

ATH434

In July 2019 we announced the completion of a clinical trial evaluating the safety and pharmacokinetics of ATH434 in healthy volunteers. The Phase 1 study, conducted in Australia, recruited 80 adult volunteers which included ten elderly people (over 65 years) with the key goals of assessing the safety, tolerability and drug disposition within the body (pharmacokinetics) of ATH434 after single and multiple oral dose administration.

The volunteers in the single ascending dose phase of the study, made up of four individual dose levels in ascending order, received a single oral dose of ATH434 and a blood sampling over the next 72 hours.