IMC Immuron Limited

By Chris Wack

Immuron Ltd. shares were up 40% to $2.26 after the company said Friday that it has received approval from the U.S. Food and Drug Administration to proceed with the clinical evaluation of Travelan.

The stock closed Thursday's session down 17%, after hitting its 52-week low of $1.39 a share.

The company said the Investigational New Drug application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli strain H10407 is now active.

As a result of this approval, the company will proceed with its planned clinical trial in the U.S. The safety and protective efficacy of Travelan will be tested using a controlled human infection-model clinical trial design.

Immuron is the sponsor of the IND. The clinical study will be conducted by the Contract Research Organization Pharmaron CPC Inc. at its FDA-inspected facility located in Baltimore.

Recruitment for the Phase II clinical trial is planned for the first half of 2023, with headline results expected by year-end 2023.

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

(END) Dow Jones Newswires

December 23, 2022 12:42 ET (17:42 GMT)

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