Immuron Gets FDA Approval to Proceed With Travelan Evaluation

By Chris Wack

Immuron Ltd. said Friday that it has received approval from the U.S. Food and Drug Administration to proceed with the clinical evaluation of Travelan.

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, and the clinical study will be conducted by the Contract Research Organization Pharmaron CPC Inc. at its FDA inspected clinical research facility located in Baltimore.

The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan in a controlled human infection model using the enterotoxigenic Escherichia coli strain H10407. Recruitment is planned to be initiated in the first half of 2023, with headline results from the clinical trial expected to be reported by year end 2023.

Immuron shares were up 55% to $2.48 in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

December 23, 2022 06:35 ET (11:35 GMT)

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