Posted: 12 April 2023
Alterity Therapeutics, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced 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 David Stamler, M.D., Chief Executive Officer, Alterity. “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 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. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.
