Biotechnology firm Alterity Therapeutics has dosed the first participant in Italy in the Phase II clinical trial of ATH434 in multiple system atrophy (MSA), a rare Parkinsonian disorder.
The placebo-controlled, randomised, double-blind trial has been designed for evaluating the safety and efficacy of ATH434 in early-stage MSA patients.
In addition to safety and pharmacokinetics assessments, the trial will evaluate ATH434 treatment’s effect on neuroimaging and protein biomarkers for demonstrating target engagement, as well as clinical endpoints for efficacy.
The company stated that the chosen biomarkers, including brain iron and aggregating α-synuclein, are said to be significant contributors to MSA pathology, and are appropriate targets to show drug activity.
It also noted that wearable sensors will be used for assessing motor activities which are said to be important to MSA patients.
Nearly 60 adult participants are anticipated to be enrolled in the Phase II clinical trial to receive one of two ATH434 dose levels or a placebo.
In the trial, the subjects will receive treatment for 12 months, which will help in detecting the changes in efficacy endpoints for optimising a definitive Phase III trial design.
Alterity Therapeutics CEO David Stamler said: “We are pleased to announce that our first participant in Europe has been dosed in our Phase II clinical trial as we look to bring a potential new treatment option to individuals living with MSA.
“We are grateful to our clinical colleagues in Italy who enrolled quickly, following approval of the study. We continue to make excellent progress advancing the trial in several countries globally.”
The oral lead candidate of Alterity ATH434 has been designed for inhibiting the aggregation of pathological proteins that are implicated in neurodegeneration.