Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has received US Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) approval to proceed with a clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhoea caused by enterotoxigenic Escherichia coli (ETEC).
The approval allows Immuron to proceed with the Travelan® Controlled Human Infection Model (CHIM) Clinical Trial in the United States and recruitment and screening of healthy volunteers has been initiated.
OHRO approval follows the approval received for the clinical trial from the US Food and Drug Administration (FDA) and the human ethics approval from the Institutional Review Board (IRB), both of which came in December 2022.
Clinical trial to start
The clinical trial to examine a dosing regimen for Travelan® more suited to the US military will be conducted by Pharmaron CPC at its FDA-inspected Clinical Research Facility Inpatient Unit in Baltimore, Maryland US.
This 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 diarrhoea (US: diarrhea).
Recruitment underway
This week Pharmaron initiated recruitment of up to 60 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years on the Pharmaron website.
It is one of three Phase 2 studies with FDA IND approval to proceed in addition to a clinical trial of Travelan® in progress by the Uniformed Services University.
Travelan® is known to protect against the onset of Travellers' Diarrhoea (TD), the most common illness reported by travellers.
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 are expected to be reported in the first half of 2024.
Four clinical trials
It is one of four clinical trials Immuron has, or is soon to, initiate. The US Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan® in up to 868 participants.
The FDA recently removed a clinical hold on two planned Phase 2 trials of Campylobacter ETEC therapeutic paving the way for initiation.
Common illness
Infectious diarrhoea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas.
Morbidity and associated discomfort stemming from diarrhoea decrease daily performance, affect judgement, decrease morale and decline operational readiness.
The first line of treatment for infectious diarrhoea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have demonstrated increasing resistance to commonly prescribed antibiotics.
In addition, Travellers' Diarrhoea is now recognised by the medical community to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome (IBS) and several post-infectious autoimmune diseases.
A preventative treatment that defends against infectious enteric diseases is a high-priority objective for the US Military.
About Travellers’ Diarrhoea
Travellers’ Diarrhoea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating and fever.
Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role.
Campylobacter spp. are also responsible for a significant proportion of cases.
The more serious infections with Salmonella spp., the bacillary dysentery organisms belonging to
Shigella spp. and Vibrio spp. (the causative agent of cholera), are often confused with Travellers’ Diarrhoea as they may be contracted while travelling and initial symptoms are often indistinguishable.