Alterity Therapeutics Gets FDA Approval for IND Application for ATH434
September 20 2022 - 8:08AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2022 07:53 ET (11:53 GMT)
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