USFDAJul 7, 2026, 06:07 AM
Alterity Therapeutics FDA Confirms ATH434 Phase 3 Registrational Path
AI Summary
Alterity Therapeutics announced it received official FDA End-of-Phase 2 meeting minutes, confirming the registrational pathway for ATH434 in Multiple System Atrophy (MSA). The FDA agreed that a single pivotal Phase 3 trial, supported by confirmatory evidence from the Phase 2 trial, could be sufficient for approval. The company is on track to initiate Phase 3 trial activities by year-end 2026, with the study expected to enroll approximately 200 patients.
Key Highlights
- FDA confirmed End-of-Phase 2 meeting minutes for ATH434 in Multiple System Atrophy (MSA).
- FDA agreed a single pivotal Phase 3 trial plus confirmatory evidence could support approval.
- Phase 3 trial activities are on track to initiate by year-end 2026.
- Phase 3 study to enroll approximately 200 patients, randomized 1:1, treated for 12 months.
- Primary endpoint: 11-item UMSARS Part I rating scale; key secondary endpoints also agreed.
- Data from ATH434-201 Phase 2 clinical trial will provide required confirmatory evidence.
- ATH434 has Fast Track Designation and Orphan Drug Designation for MSA.
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