Multiple system atrophy therapy
Alterity Therapeutics has received authorization 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 leading candidate of the company, ATH434 can hinder the accumulation of pathological proteins involved in neurodegeneration.
The randomized, double-blind, placebo-controlled trial will analyze ATH434 in early-stage MSA patients.
It will enroll 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 characterization 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 enrollment in New Zealand and regulatory authorizations in the UK and Italy, we focus 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.