Globally integrated biopharmaceutical company Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has initiated the second cohort of a clinical trial aimed at assessing the effectiveness of Travelan® in preventing infectious diarrhoea caused by enterotoxigenic Escherichia coli (ETEC).
This pivotal study represents a significant step forward in addressing the issue of travellers' diarrhoea, particularly among US military personnel deployed overseas.
34 participants
The Phase 2 clinical trial, which follows the completion of a first cohort in August 2023, now includes 34 participants who have been randomised to receive either Travelan® or a placebo.
It has been 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 diarrhoea.
The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for two weeks, one month and six month follow-up visits.
The clinical study’s six-month follow-up of cohorts one and two is expected to be completed in April 2024. With headline results reported in June of that year.
Principal investigator Dr Mohamed Al-Ibrahim is overseeing the study at the Pharmaron CPC FDA-inspected Clinical Research Facility Inpatient Unit in Baltimore, Maryland, USA.
Diarrhoea impairs performance
Infectious diarrhoea is a prevalent ailment among travellers visiting developing countries and military personnel deployed overseas. It not only impairs daily performance but also affects judgment, morale and operational readiness.
Traditionally, antibiotics have been prescribed as the first-line treatment for infectious diarrhoea – but the rise in antibiotic-resistant enteric pathogens in recent years has raised concerns about this approach.
Furthermore, travellers' diarrhoea is now understood to be linked to post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and autoimmune diseases.
Travelan® offers a promising alternative as a preventive treatment against infectious enteric diseases. This clinical trial's results, expected to be reported in June 2024, may hold the key to improving the well-being and operational effectiveness of travellers and military personnel alike.