Alterity Therapeutics has dosed the first patient in Australia in its Phase II clinical trial of ATH434 for the treatment of early-stage multiple system atrophy (MSA), a debilitating Parkinsonian disorder.
The placebo-controlled, randomised, double-blind study will evaluate the safety and pharmacokinetics properties of ATH434 in more than 60 adult subjects.
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Patients will receive one of two ATH434 dose levels or placebo for 12 months and the efficacy endpoints obtained further enable in designing a definitive Phase III study.
The effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement will also be assessed in the study along with clinical endpoints to demonstrate efficacy.
Drug activity is demonstrated using brain iron and aggregating α‑synuclein biomarkers, which are said to be important contributors to MSA pathology.
Motor activities in patients with MSA are also evaluated using wearable sensors.
Dr Stephen Tisch from St Vincent’s Hospital in Sydney is the principal investigator of the trial.
Alterity Therapeutics CEO David Stamler said: “The dosing of our first MSA participant in Australia is an important milestone as we are now enrolling in five countries around the world.
“The trial has been well received by physicians as we are using state-of-the-art methods to diagnose and track the disease.
“We are grateful to Dr Tisch and the team at St Vincent’s Hospital for their ongoing efforts to advance the development of ATH434.”
An estimated 15,000 individuals in the US have MSA.
