Alterity Therapeutics has started a new Phase II clinical trial of ATH434 for the treatment of Multiple System Atrophy (MSA), a rare, neurodegenerative disease.
The open-label study will enrol up to 15 individuals with more advanced MSA to evaluate the safety, pharmacokinetics and clinical measures of ATH434.
It will also assess the efficacy of ATH434 on neuroimaging and protein biomarkers that measure target engagement and are relevant to the underlying disease pathology.
The selected biomarkers including brain iron and aggregating α‑synuclein are said to be key contributors to determining the pathology of MSA and are appropriate targets to demonstrate the activity of the drug.
With the first patient enrolled, participants will receive ATH434 for 12 months.
Evaluating the impact of 12 months of treatment with ATH434 on brain iron by MRI (QSM/R2) in a more advanced patient population is the primary objective of the study.
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In addition to the biomarker trial for advanced MSA, Alterity’s placebo-controlled, randomised, double-blind Phase II trial in early-stage MSA is ongoing.
Alterity Therapeutics CEO David Stamler said: “The data derived from these two trials will help us optimise and potentially accelerate future development.
“Importantly, the randomised Phase II trial is proceeding as planned, but the design of this new study will allow us to perform interim analyses of biomarker data during conduct, which could give us early indications of efficacy.
“We expect to have preliminary data from an initial cohort of enrolled participants before the randomised study reads out.”