IMC Immuron Limited

By Chris Wack

Immuron Ltd. said it was awarded 4.8 million Australian dollars ($3.4 million) in funding in a new research agreement with the U.S Department of Defense a study to clinically evaluate a military strength dosing regimen for Travelan.

The biopharmaceutical company said the U.S. Naval Medical Research Center received A$1.4 million in funding to support the Travelan clinical development effort.

The company said the focus of the new agreement is aimed at testing and confirming the efficacy of a single larger dose regimen of Travelan in a controlled human infection model clinical study using the enterotoxigenic Escherichia coli strain H10407.

Immuron said this single larger dosing regime is potentially more amenable for use in military populations. Up to 60 volunteers will be enrolled in the clinical study and will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan or placebo.

Results of the proposed clinical study will also inform on dosing in the pivotal Phase 3 registration trials for Biologics License Application licensure. A project kickoff meeting for this award has been scheduled for the end of January with the U.S government sponsors.

The company said two company-sponsored clinical studies have demonstrated that Travelan conferred 84% to more than 90% protective efficacy against moderate to severe diarrhea upon challenge with ETEC in comparison with a placebo. These clinical studies were performed using two different doses of Travelan, 200 mg and 400 mg, administered three times a day. Ongoing discussions with Army and Navy leadership have highlighted that such a regimen is cumbersome for military personnel deployed in austere environments and military field studies have shown that compliance is low with products dosed more than once per day.

Immuron shares were up 48% to $3.87 in premarket trading.

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

(END) Dow Jones Newswires

January 12, 2022 06:40 ET (11:40 GMT)

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