Posted: 26 July 2023
Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has enrolled its first cohort of 30 participants into the Travelan® clinical trial to evaluate its efficacy to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
Travelan® is known to protect against the onset of travellers’ diarrhea (TD), the most common illness reported by travellers.
The study is being led by Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA-inspected Clinical Research Facility Inpatient Unit in Baltimore, Maryland US.
This Phase 2 trial aims to test Travelan®’s safety and its ability to protect against infection, compared to a placebo, in a controlled human infection model (CHIM).
It is also examining a dosing regimen for Travelan® more suited to the US military.
The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525.
Completion of dosing in the first cohort is expected in the first week of August 2023. The final cohort of 30 participants is expected to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023.
Headline results from the clinical trial are expected to be reported in 1H 2024.
US military studies
A second study is being conducted by the US Department of Defense Uniformed Services University (USU), which is running a randomised clinical trial with Travelan® in up to 868 participants. ClinicalTrials.gov Identifier: NCT04605783.
So far, the USU has enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study.
The enrolment period for this study has been extended, with clinical trial enrolment expected to be finished in Q2 2024.
Travellers visiting developing countries and US troops stationed abroad commonly suffer from infectious diarrhea. This illness can reduce daily performance, impair judgement, lower morale and compromise operational readiness due to the associated discomfort and health issues.
Antibiotics are typically the initial treatment for infectious diarrhea, but many intestinal pathogens have shown growing resistance to these drugs over the last decade.
Moreover, the medical community now acknowledges that TD can lead to subsequent health issues like post-infectious irritable bowel syndrome (IBS) and various autoimmune diseases. Given these complications, the US Military is prioritising the development of preventative treatments against infectious intestinal diseases.
