Alterity Therapeutics (ASX:ATH) has announced that the first participant has been dosed in the United Kingdom in the company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA).
“MSA is a rare and highly debilitating Parkinsonian disorder, and our Phase 2 clinical program is designed to evaluate the effects of ATH434 in individuals with early-stage disease with no current therapeutic treatment options,” said Alterity CEO Dr David Stamler.
“With sites open in five countries, the clinical trial is steadily enrolling globally, and the enrollment of our first patient in the United Kingdom expands our reach in Europe.”
The Phase 2 clinical trial is a randomised, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA.
The company said the study would evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics.
The selected biomarkers, including brain iron and aggregating α‑synuclein, are important contributors to MSA pathology and are appropriate targets to demonstrate drug activity.
Wearable sensors will also be employed to evaluate motor activities important to MSA patients.
The study is expected to enrol approximately 60 adults to receive one of two dose levels of ATH434 or a placebo. Participants will receive treatment for 12 months, providing an opportunity to detect changes in efficacy endpoints to optimise the design of a definitive Phase 3 study.