USFDAJun 9, 2026, 07:07 AM
Alterity Therapeutics Secures FDA Alignment for ATH434 Phase 3 MSA Trial
AI Summary
Alterity Therapeutics announced a successful End-of-Phase 2 meeting with the U.S. FDA for ATH434 in Multiple System Atrophy (MSA). The FDA agreed on key elements of the proposed Phase 3 design, including the study population, dosing regimen (50mg twice daily), treatment duration, and UMSARS Part I as the primary endpoint. This agreement de-risks the registrational program, with Phase 3 trial activities expected to commence by year-end 2026.
Key Highlights
- FDA agreed on key elements of the proposed Phase 3 design for ATH434 in Multiple System Atrophy (MSA).
- FDA concurred with UMSARS Part I as the primary endpoint for the Phase 3 study.
- FDA agreed with the 50mg dose level, which showed 48% slowing of disease progression in Phase 2.
- FDA found planned key secondary endpoints and statistical methods suitable for efficacy support.
- Pivotal Phase 3 trial activities are on track to initiate by year-end 2026.
- ATH434 previously received Fast Track and Orphan Drug Designations from the FDA for MSA.
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