– Official FDA minutes confirm the previously announced End-of-Phase 2 meeting outcomes and provide additional detail on the planned Phase 3 protocol —
– FDA agreed that a single pivotal Phase 3 trial plus confirmatory evidence could support an approval of ATH434 for the treatment of MSA –
– Pivotal Phase 3 trial activities on track to initiate by year-end 2026 –
MELBOURNE, Australia and SAN FRANCISCO, July 07, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that it has received the official meeting minutes from its End-of Phase-2 (EOP2) meeting for ATH434 in Multiple System Atrophy (MSA) from the U.S. Food and Drug Administration (FDA). The minutes confirm the key elements of the registrational Phase 3 program previously announced on 9 June 2026 and the path toward a potential New Drug Application (NDA) filing.
"The official meeting minutes confirm the alignment we reached with the FDA and provide a well-defined clinical development strategy for registration," said David Stamler, M.D., Chief Executive Officer. "The FDA's willingness to accept a single pivotal trial supported by confirmatory evidence reflects a clear pathway for ATH434 in MSA. With the Phase 3 design elements confirmed, we are finalizing the protocol and remain on track to initiate Phase 3 trial activities by year-end 2026."
Dr. Daniel Claassen, MD, Chief Medical Advisor, commented: "The Phase 2 results for ATH434 were among the most encouraging I have seen in the field, and the alignment reached with the FDA on the Phase 3 trial design is an important next step in bringing a meaningful new treatment option to people living with this devastating disease."
The EOP2 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 (SDQ), the Orthostatic Hypotension Symptom Assessment (OHSA), and the Clinical Global Impression of Severity (CGI-S). 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.