Alterity Therapeutics has received authorisation from the Italian Medicines Agency or Agenzia Italiana del Farmaco (AIFA) to carry out a Phase II clinical trial of ATH434 for multiple system atrophy (MSA).
A lead candidate of the company, ATH434 can hinder the accumulation of pathological proteins involved in neurodegeneration.
The randomised, double-blind, placebo-controlled trial will analyse ATH434 in early-stage MSA patients.
It will enrol nearly 60 adults who will be given either ATH434 or a placebo.
The impact of ATH434 on imaging and protein biomarkers, such as aggregating α-synuclein and excess iron, which are crucial contributors to the pathology of MSA, will be assessed in the trial.
Clinical and biomarker endpoints, including the usage of wearable sensors, will aid in the complete evaluation of the efficacy of ATH434 as well as the characterisation of its safety and pharmacokinetics.
Trial subjects will be treated for 12 months which will offer an opportunity to identify variations in efficacy endpoints to enhance the Phase III trial design.
Alterity Therapeutics CEO David Stamler said: “Approval by the Italian authorities provides another endorsement of the approach we are taking with our Phase II clinical trial.
“With our trial now open for enrolment in New Zealand and regulatory authorisations in the UK and Italy, we are focused on opening study sites in these regions and expanding access to other countries throughout the year.”
In preclinical research, ATH434 showed to lower α-synuclein pathology and offer protection for nerve cells by reinstating normal iron balance in the brain.
In a concluded Phase I trial, the agent was found to be well-tolerated, orally bioavailable and attained brain levels in line with efficacious levels in animal models of MSA.
A rare neurodegenerative ailment, MSA is characterised by autonomic nervous system failure and impaired movement.
Earlier this month, the company commenced the Phase II trial of ATH434 to treat MSA in New Zealand.