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ATH Alterity Therapeutics Ltd

0.0045
0.0005 (12.50%)
20 Jun 2024 - Closed
Delayed by 20 minutes
Share Name Share Symbol Market Type
Alterity Therapeutics Ltd ASX:ATH Australian Stock Exchange Ordinary Share
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.0005 12.50% 0.0045 0.004 0.005 0.005 0.0045 0.005 525,000 04:43:40

Alterity Therapeutics Gets FDA Approval for IND Application for ATH434

20/09/2022 1:08pm

Dow Jones News


Alterity Therapeutics (ASX:ATH)
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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)

Copyright (c) 2022 Dow Jones & Company, Inc.

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