By Chris Wack

Alterity Therapeutics Ltd. shares reversed course Tuesday, dropping 13% to 49 cents, after the company said it received approval for its investigational new drug application by the Food and Drug Administration to allow evaluation of ATH434 in individuals with Multiple System Atrophy, a rare and highly debilitating Parkinsonian disorder.

The stock was trading as much as 20% higher in premarket trade, but hit its 52-week low of 40 cents a share in morning trading.

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

The Phase 2 clinical trial will explore the effect of ATH434 treatment on neuroimaging and protein biomarkers. Clinical endpoints will 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 will receive treatment for 12 months, which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 20, 2022 13:10 ET (17:10 GMT)

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