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FDA agrees to Phase 3 design including UMSARS Part I as primary endpoint.
Alterity Therapeutics Ltd (Nasdaq: ATHE) announced alignment with the U.S. Food and Drug Administration (FDA) on the pivotal Phase 3 ATH434 program for Multiple System Atrophy (MSA). The FDA has agreed to the Phase 3 design, which includes the Unified Multiple System Atrophy Rating Scale (UMSARS) Part I as the primary endpoint.
The alignment with the FDA is a critical step forward for the ATH434 program, ensuring that the trial design meets regulatory expectations and focuses on clinically meaningful outcomes for patients with MSA.
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