Alterity Therapeutics (ATHE) Expands Phase 2 Clinical Development Program ATH434



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Alterity Therapeutics (NASDAQ: ATHE), a biotechnology company dedicated to the development of disease-modifying therapies for neurodegenerative conditions, today announced the expansion of the clinical development program of the Company’s core asset, ATH434, in patients with multisystem atrophy (MSA), a rare disease and rapidly progressive parkinsonian disorder. ATH434 has been shown to reduce the abnormal accumulation of -synuclein by restoring normal iron balance in the brain with the aim of improving motor function in patients with ASM and Parkinson’s disease.

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers such as -synuclein aggregation and excess iron, which are important contributors to MSA pathology. Several other biomarkers and clinical parameters will allow a complete evaluation of the efficacy of ATH434 as well as a characterization of the safety and pharmacokinetics. Based on consultations with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and clinical experts in MSA, Alterity has established that patients will receive treatment for 12 months within the phase 2 study. The longer treatment duration will provide a better opportunity to detect changes in biomarkers and clinical parameters in order to optimize the design of a definitive phase 3 study.

In addition, the natural history study Biomarkers of Progression in Multiple Systems Atrophy (bioMUSE) has met its initial recruitment target and will be expanded to a total of 20 patients with ASM. The study has proven invaluable in generating data to inform and reduce the risks of the Phase 2 trial design, and it will continue to provide longitudinal biomarkers and clinical data to characterize disease progression in a patient population that reflects those who will be recruited in the phase 2 study.

“With our planned Phase 2 clinical trial and the expansion of bioMUSE, we have created a robust development program to advance ATH434 for the treatment of AMS,” said David Stamler, MD, CEO of Alterity . “By restoring normal iron balance in the brain, ATH434 has the potential to block -synuclein aggregation, preserve neurons, and treat the underlying pathology of AMS. this approach to alter the progression of the disease will have a profound impact on the quality of life for people living with MSA, a devastating disease with very few treatment options. “

Dr Stamler continued, “It is important to note that our Phase 2 clinical trial incorporates regulatory commentary, expert advice and essential learnings from bioMUSE to establish an optimal trial design with a better overall chance of success. . investigators and look forward to starting the trial in the first quarter of calendar year 2022. “

The double-blind phase 2 clinical trial is a three-arm study where patients with early stage MSA will be randomized to receive one of two doses of ATH434 or a placebo, given twice daily . Early-stage patients with a clinical diagnosis of ASM who are ambulatory, have no signs of severe impairment, and do not have long-standing motor symptoms will be included in the study. The trial is expected to enroll 60 early-stage patients at around 30 sites in Australia, New Zealand, Europe and the United States. 2 clinical trial informing patient selection and confirming that iron content in brain is a promising biomarker. Based on this data, Alterity believes that treating patients at the early stage of their disease will offer the best chance of improvement over ATH434.

About Hector Hedgepeth

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