Alterity Therapeutics meeting with US FDA provides development pathway for ATH434
Alterity Therapeutics Limited - American Depositary Shares (ATHE)
Company Research
Source: PR Newswire
MELBOURNE, Australia and SAN FRANCISCO, June 29, 2020 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company") is pleased to announce that it has received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple System Atrophy (MSA), a Parkinsonian disorder. The company recently met with the FDA following the successful completion of its Phase 1 clinical trial last year and further data analysis. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design. Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects of the Company's Phase 2 study design including the proposed patient population, safety monitoring plan, and strategy
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