Posted: 17 March 2023
Alterity Therapeutics, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, announced the first participant has been dosed in the U.S. in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.
“The U.S. is an important region for our ATH434 Phase 2 clinical trial, and we are thrilled to have dosed our first patient at Vanderbilt University Medical Center,” said David Stamler, M.D., Chief Executive Officer, Alterity. “Our colleagues at Vanderbilt are long-time supporters of the ATH434 development program and we are grateful for their continued efforts. The Phase 2 trial is gaining momentum with active recruitment in five countries, as we look to bring a potential new treatment option to individuals living with MSA.”
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.
