“U.S. FDA Fast Track designation for ATH434 in MSA was the highlight of the recent quarter that also featured additional positive clinical data from our Phase 2 double-blind trial,” said David Stamler, M.D., Chief Executive Officer of Alterity. “Receiving Fast Track Designation alongside the Orphan Drug Designation we have already received underscores the promise of this potentially disease modifying therapy to address the urgent needs of individuals with MSA. In addition, we presented additional efficacy data from the ATH434-201 double-blind trial at prominent medical meetings, including slowing of disease progression on the Unified MSA rating scale or UMSARS, improvement in key symptoms of MSA, and preserved activity in the outpatient setting. We were also very pleased to announce positive results from our ATH434-202 open-label Phase 2 clinical trial this week, in which ATH434 demonstrated a clinical benefit on the UMSARS and global assessments of neurological symptoms. Neuroimaging biomarkers showed target engagement and slowed brain atrophy in a manner consistent with the double-blind study findings. Importantly, ATH434 continues to demonstrate a favorable safety profile. These data reinforce our confidence in the MSA program as we prepare for interactions with the U.S. FDA,” concluded Dr. Stamler.
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