Immuron: FDA Allows To Proceed With Clinical Evaluation Of Travelan

(RTTNews) - Immuron Limited (IMRN) said the company's Investigational New Drug application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli or ETEC is now active. Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC, Inc at its FDA inspected clinical research facility located in Baltimore, Maryland.

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

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