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Alterity Therapeutics has received the St. Vincent’s Hospital Melbourne Human Research Ethics Committee’s (HREC) approval to begin the Phase II clinical trial of ATH434 in Australia to treat multiple system atrophy (MSA).

The company has also opened patient enrolment at its first clinical trial site in Sydney.  

The placebo-controlled, randomised, double-blind trial will assess ATH434’s efficacy and safety in early-stage MSA patients.

Nearly 60 adult patients are expected to be enrolled and will be given one of two doses of ATH434 or a placebo in the study.

In the trial, the impact of treatment with ATH434 on neuroimaging and protein biomarkers, including excess brain iron and aggregating α-synuclein, which are said to be crucial contributors to the pathology of MSA, will be assessed.

Alterity stated that the clinical endpoints will support the complete evaluation of the efficacy of ATH434, as well as the characterisation of pharmacokinetics and safety.

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The trial participants will be treated for 12 months, which will offer a chance for identifying the variations in efficacy endpoints to optimise the Phase III trial design.

Alterity CEO David Stamler said: “We are thrilled to receive ethics approval and launch our first clinical trial site for enrolment in Australia.

“ATH434 is designed to slow the progression of MSA and we are eager to increase access to our study of this potential disease modifying treatment.

“Our Phase II programme has now received regulatory authorisation in five countries, with three locations actively recruiting participants in the trial.”

The oral agent, ATH434 has been designed to block the aggregation of pathological proteins involved in neurodegeneration.