Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, has announced positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Type C Meeting regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy (MSA). The Type C Meeting is part of a strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA.
Alterity received written feedback supporting its plans related to the clinical pharmacology and non-clinical development elements of the program. David Stamler, M.D., Chief Executive Officer of Alterity, stated that the meeting confirms alignment with the FDA in two key disciplines and represents an important step toward initiation of the Phase 3 program.
In addition, Alterity will also be seeking agreement with the FDA on Chemistry, Manufacturing, and Controls (CMC) and the Phase 3 trial design. The company anticipates this favorable outcome sets the stage for future discussions, with an End-of-Phase 2 meeting remaining on track for mid-year 2026.
Alterity Therapeutics is focused on developing disease modifying therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. The company is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, Alterity’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with MSA.
