Alterity Therapeutics receives FDA meeting minutes on pathway for ATH434

Alterity Therapeutics announced that it has received the official meeting minutes from its End-of Phase-2 meeting for ATH434 in Multiple System Atrophy from the FDA. The minutes confirm the elements of the registrational Phase 3 program previously announced on June 9 and the path toward a potential new drug application filing. The minutes confirmed that the FDA agreed with the proposed Phase 3 trial design, including the study population, treatment regimen, and efficacy endpoints. Alignment was reached on the selection and analysis of the primary endpoint - the 11-item UMSARS Part I1 rating scale, a functional measure of activities of daily living affected in MSA. Agreement was also reached on selection of key secondary endpoints, including the Swallowing Disturbance Questionnaire, the Orthostatic Hypotension Symptom Assessment and the Clinical Global Impression of Severity. The Phase 3 study is expected to enroll approximately 200 patients who will be randomized in a 1:1 ratio and treated with ATH434 50 mg or matching placebo twice daily for 12 months. The FDA further indicated that a single pivotal trial plus confirmatory evidence could provide the necessary data to support an.