Alterity Therapeutics Reaches US FDA Alignment on Phase Three Trial for Neurodegenerative Disorder Treatment Candidate
Alterity Therapeutics (ASX:ATH) reached agreement with the US Food and Drug Administration (FDA) on the key elements of its phase three registrational trial for ATH434 in multiple system atrophy, a neurodegenerative disorder, following a positive end-of-phase two meeting, according to a Tuesday statement by the company after market hours.The US FDA endorsed the proposed study design, including the patient population, treatment duration, and primary endpoint based on part one of the 11-item unified multiple system atrophy rating scale, as well as the selected dosing regimen of 50 milligram administered twice daily.Secondary endpoints including swallowing function, orthostatic hypotension symptoms, and global clinical severity were deemed appropriate, with agreement on statistical methods and safety database size.This alignment reduces risk in the pivotal phase three trial and strengthens the pathway toward a potential new drug application submission, with ATH434 already holding fast track and orphan drug designations from the FDA for multiple system atrophy, the company said.
