Alterity Therapeutics (ASX:ATH) has announced that the last patient in its ATH434-201 Phase 2 trial in early-stage multiple system atrophy has completed the study.
Multiple system atrophy (MSA) is a rare, neurodegenerative disease characterised by the failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability.
The trial is a randomised, double-blind, placebo-controlled investigation. It is evaluating 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 trial enrolled 77 adults randomly assigned to receive one of two dose levels of ATH434 or placebo. Alterity said it expects topline results to be reported in late January or early February 2025.
“We are very excited to announce that the last participant in our Phase 2 study has completed all clinical evaluations, the final milestone that starts the clock to reporting topline data in this rare neurodegenerative disease,” said Alterity CEO Dr David Stamler.
“The completion of our ATH434-201 trial represents a major accomplishment for Alterity, and I would like to recognise the trial participants for their involvement in the study. I would also like to thank our clinical sites and our study team for their hard work and dedication in conducting the trial. Throughout the course of the trial, we have had tremendous interest from our clinical sites, doctors and patients around the globe as we seek a treatment that could potentially slow the progression of this devastating disease. With the last patient visit behind us, we can now focus our attention on cleaning and locking the database and reporting topline data early next year.”
