The US Naval Medical Research Command (NMRC) has initiated the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron Ltd (NASDAQ:IMRN, ASX:IMC).
The NMRC has prioritised the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter.
Developing a preventive therapy to safeguard against infectious intestinal diseases is a top priority for the United States Military.
The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit at the JHU Bayview Medical Campus in Baltimore.
A preventative treatment that defends against infectious enteric diseases is a high-priority objective for the US Military.
Preventing moderate to severe diarrhea
The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product 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. ClinicalTrials.gov Identifier: NCT06122870.
The dosing, challenge and in-patient stage of the study is anticipated to be completed by the third week of December 2023. The estimated study completion date (last participant, last visit) is June 2024 with headline results from the clinical trial expected to be reported in 2H 2024.
Infectious diarrhea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgement, decreases morale and declines operational readiness.
The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have demonstrated increasing resistance to commonly prescribed antibiotics.
In addition, traveller’s diarrhea 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.
What is traveller’s diarrhea?
Travelers (NYSE:TRV)' diarrhea is a gastrointestinal infection that presents with symptoms such as loose, often watery, and sometimes bloody stools, accompanied by abdominal cramps, bloating, and fever. The majority of these cases are caused by enteropathogenic bacteria, with enterotoxigenic Escherichia coli (ETEC) being a primary culprit.
Campylobacter spp. also contributes to a significant number of cases.
More severe infections caused by Salmonella spp., Shigella spp. (responsible for bacillary dysentery), and Vibrio spp. (the pathogen behind cholera), are frequently mistaken for travellers' diarrhea. This confusion arises because they can be contracted during travel and their initial symptoms are very similar.