Alterity To Initiate Phase 3 Trial Of ATH434 In MSA Subsequent To Receipt Of EOP2 Minutes From FDA

India, July 7 -- Alterity Therapeutics Ltd. (ATHE), a clinical-stage biotechnology company, announced that it has received the U.S. Food and Drug Administration's meeting minutes from the End-of Phase 2 or EOP2, for ATH434 in the treatment of Multiple System Atrophy, or MSA.

The minutes confirm a potential Phase 3 trial design, including study population, treatment regimen, and efficacy endpoints. ATH434 is an oral lead candidate designed to reduce iron accumulation and inhibit abnormal protein aggregation associated with neurodegeneration.

The FDA indicated that a single pivotal Phase 3 trial, together with confirmatory evidence, could support an approval of ATH434 for the treatment of MSA. Alterity expects to initiate the pivotal Phase ...