- Alterity Therapeutics (ATH) expands its clinical development program for lead asset ATH343 in patients with Multiple System Atrophy (MSA)
- The study is expected to enrol 60 early-stage patients at roughly 30 sites across Australia, New Zealand, Europe and the US
- This work will explore the effect of the treatment on imaging and protein bio markers and test the drug’s safety and efficacy
- ATH says learnings from its bioMUSE study will inform the phase two trial
- Shares are trading in the grey at 3.1 cents each at 3:28 pm AEDT
Alterity Therapeutics (ATH) is expanding the phase two clinical development program for its lead asset ATH434 in patients with Multiple System Atrophy (MSA).
Based in Melbourne and San Fransisco, ATH is a biotechnology company dedicated to developing disease-modifying treatments for neurodegenerative conditions.
MSA is one such condition that is categorised as a rare and rapidly progressive Parkinsonian disorder.
Notably, ALT said its drug had been shown to restore normal balance in the brain, with the objective to improve motor function in patients who have MSA or Parkinson’s disease.
Phase two clinical trial
The phase two clinical trial is designed as a randomised, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA.
This work is expected to enrol 60 early-stage patients at around 30 sites in Australia, New Zealand, Europe and the US.
The study will explore the effect of the treatment on imaging and protein biomarkers, such as aggressive a-synuclein and excess iron, which are important contributors to MSA pathology.
Further, the work will examine the efficacy and safety of the drug.
Alterity said that based on consultations with the US Food and Drug Administration, European Medicines Agency and clinical experts, the company determined patients would receive treatment for 12 months in phase two.
The longer treatment duration is intended to provide a better opportunity to detect changes in biomarkers and clinical endpoints to optimise the design of a definitive phase three study.
Alterity’s CEO David Stamler said the company had created a robust development program to advance ATH434 for the treatment of MSA.
“By restoring normal iron balance in the brain, ATH434 has the potential to block a-synuclein aggregation, preserve neurone, and treat the underlying pathology of MSA,” Dr Stamler said.
“If successful, this approach to modifying disease progression will have a profound impact on the quality of life for individuals living with MSA, a devastating disease with very few treatment options.”
bioMUSE update
Meanwhile, ATH said its Biomarkers of Progression in Multiple Systems Atrophy (bioMUSE) natural history study had reached its original enrolment goal and would be expanded to a total of 20 patients with MSA.
Importantly, Dr Stamler said the phase two clinical trial would integrate regulatory feedback, expert advice and critical learnings from bioMUSE to establish an optimal trial design with an improved overall chance of success.
“There has been great interest in our program from prospective investigations and we look forward to initiating the trial in the first quarter of calendar year 2022,” he said.
Shares were trading in the grey at 3.1 cents each at 3:28 pm AEDT.