Posted: 8 March 2023
Alterity Therapeutics, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant in Italy has been dosed in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.
“We are pleased to announce that our first participant in Europe has been dosed in our Phase 2 clinical trial as we look to bring a potential new treatment option to individuals living with MSA,” said David Stamler, M.D., Chief Executive Officer, Alterity. “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 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will 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 therefore appropriate targets to demonstrate drug activity. Wearable sensors will also be employed to evaluate motor activities that are important to patients with MSA. The study is expected to enroll approximately 60 adults to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.
