Immuron submits IND application for Travelan to FDA

Immuron is pleased to announce that it has submitted an Investigational New Drug application to the U.S. FDA for Travelan. 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. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan or placebo. Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA . Dr. Mohamed Al-Ibrahim, MB, ChB, FACP will be the Principal Investigator for the study with recruitment planned to commence in 1H 2023 subject to FDA approval with headline results from the clinical trial expected to be reported by year end 2023.