Alterity Therapeutics Gets FDA Approval for IND Application for ATH434

By Chris Wack

Alterity Therapeutics Ltd. said it has received approval from the U.S. Food and Drug Administration for its Investigational New Drug application to allow evaluation of ATH434 in individuals with Multiple System Atrophy, a rare and highly debilitating Parkinsonian disorder.

The company said the approval of this IND authorizes it to conduct its Phase 2 clinical trial in the U.S.

The trial is expected to explore the effect of ATH434 treatment on neuroimaging and protein biomarkers. Clinical endpoints would permit comprehensive assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics.

The study is expected to enroll 60 adult patients to receive one of two dose levels of ATH434 or placebo. Patients would receive treatment for 12 months which would provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.

Alterity shares were up 20%, to 67 cents, in premarket trade.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

September 20, 2022 07:53 ET (11:53 GMT)

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