By Chris Wack

 

Immuron Ltd. said Tuesday that it has executed a master service agreement with U.S.-based Pharmaron CPC Inc.

The biopharmaceutical company said its clinical trial agreement will allow for a Phase II trial to evaluate the efficacy of a single dose regimen of Travelan in a controlled human infection model using the enterotoxigenic Escherichia coli strain H10407.

Travelan is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers' diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce.

The new planned clinical study will enroll up to 60 volunteers. Each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan or a placebo. The proposed clinical development program is being funded in part by a $4.5 million award from the U.S. Department of Defense.

Immuron is currently on track to submit the Investigational New Drug application to the U.S. Food and Drug Administration by end of 2022, and will be the sponsor of the clinical study, which is planned to begin in the first half of 2023, with headline results from the clinical trial expected in the second half of 2023.

 

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

 

(END) Dow Jones Newswires

October 04, 2022 06:30 ET (10:30 GMT)

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