Immuron has kickstarted its Phase II trial investigating the efficacy of its tablet for infectious diarrhoea caused by Enterotoxigenic Escherichia coli (ETEC).

Also known as Travellers' diarrhoea, the condition is often experienced by individuals visiting foreign countries and is contracted by eating contaminated food or water.

Australian biopharma company Immuron is conducting a trial (NCT05933525) comparing its candidate Travelan (IMM-124E) against a placebo after challenge with an ETEC strain. The company has completed the first cohort enrolment of 30 participants. A second cohort of 30 patients is expected to be enrolled by October 2023.

Dosing and the in-patient stage of the study’s first cohort are expected to be completed by the first week of August 2023. Headline results from the clinical trial are expected in the first half of 2024. 

Immuron’s treatment aims to prevent the infection as opposed to treating it once symptoms have started. Participants will begin the regimen two days prior to the ETEC challenge. Six Travelan tablets (1200mg) will be orally administered over seven days.

Participants will also be given ciprofloxacin 500 mg by mouth twice daily for three days – standard of care treatment – five days after the challenge unless early treatment criteria are met.

The primary endpoint measuring the efficacy is the number of subjects to encounter moderate to severe diarrhoea. Each patient’s stool sample will be graded by how watery it is.

Travellers' diarrhoea is also common amongst military personnel stationed in overseas countries. The US Department of Defense Uniformed Services University is also running its own randomised clinical trial (NCT04605783) with Travelan in up to 868 participants.