Alterity Therapeutics (ASX:ATH) has announced that the US FDA has granted fast track designation for ATH434 for treating Multiple System Atrophy (MSA).
ATH434 is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. It has been shown in pre-clinical studies to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models. Alterity said positive results from the randomised, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated robust clinical efficacy, target engagement on key biomarkers, and a favourable safety profile.
The fast track designation is intended to accelerate the development and review of novel investigational products.
“Receiving the FDA’s Fast Track Designation for ATH434, alongside the Orphan Drug Designation we have already received, underscores the promise of this novel agent to address the urgent need for a disease modifying therapy for individuals with MSA,” said Alterity CEO Dr David Stamler.
“This designation reinforces the potential of ATH434 as demonstrated by recent scientific findings related to its mechanism of action and the robust and clinically meaningful efficacy from our double-blind Phase 2 clinical trial. Importantly, the Fast Track designation provides us the opportunity to interact with the FDA more frequently on the advancement of ATH434, potentially accelerating its development path and approval. We look forward to leveraging the Fast Track designation to bring this promising treatment to patients as quickly as possible."
