Alterity Therapeutics Says FDA Backs Phase 3 Design for Multiple System Atrophy Therapy

Alterity Therapeutics (ATHE) said Tuesday the US Food and Drug Administration's end-of-phase 2 meeting minutes confirmed agreement on the key elements of the registrational phase 3 trial for ATH434 in multiple system atrophy. The company said the FDA agreed with the proposed phase 3 design, including the study population, treatment regimen and primary endpoint, with the trial expected to enroll about 200 patients. Phase 3 trial activities are expected to begin by the end of 2026, Alterity said. The health agency also indicated that a single pivotal phase 3 trial, supported by confirmatory evidence from the phase 2 study, could support a potential New Drug Application filing or approval, the company added.