Immuron Limited announced that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan(R) to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022). Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment.

The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan®? compared to a placebo in a controlled human infection model (CHIM).

The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. The first cohort of 30 participants is anticipated to be enrolled and dosed by the end of July 2023. The final 30 participants are anticipated to be enrolled into the study in October 2023.

Headline results from the clinical trial expected to be reported in 1H 2024. This is one of four clinical trials Immuron has, or is soon to, initiate. The U.S. Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan(R) in up to 868 participants.

The U.S. department of Defense Uniformed Services University are running a randomized clinical trial of travelan(R) in up To 868 participants. The U.,S. Department of Defense Uniforming Services University is running a randomizedclinical trial of Travelan®? in up to 868 participants (ASX announcement January 18, 2023).

ClinicalTrials.gov Identifier: NCT04605783.