Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical Study

Rhea-AI Summary

Immuron Limited (IMC; IMRN) announces the initiation of a clinical trial by the US Naval Medical Research Command to evaluate the efficacy of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections. The study aims to prevent infectious diarrhea, a common illness among travelers and US troops deployed overseas. The estimated study completion date is June 2024, with headline results expected in 2H 2024.

Highlights:

• First participants enrolled in the US Naval Medical Research Command Clinical Trial
• Clinical Study initiated to evaluate the efficacy of a new Immuron clinical product to protecting volunteers against moderate to severe campylobacteriosis
• New CampETEC product is a prophylactic therapeutic designed to protect against Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections, two of the major causes of Travelers’ diarrhea
• The in-patient stage of the study is anticipated to be completed by the end of December 2023

MELBOURNE, Australia, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that 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. The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter.

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, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. 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 the 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 travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, 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, traveler’s diarrhea is now recognized 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.

This release has been authorised by the directors of Immuron Limited.

COMPANY CONTACT: Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 info@immuron.com

About Travelers’ diarrhea

Travelers’ diarrhea 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 travelers’ diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable.

About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases.

For more information visit: http://www.immuron.com

FAQ

What is the clinical trial initiated by the US Naval Medical Research Command?

The US Naval Medical Research Command has initiated a clinical trial to evaluate the efficacy of a new oral therapeutic developed in collaboration with Immuron targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections.

What is the primary objective of the clinical trial?

The primary objective is to prevent and/or reduce moderate to severe diarrhea caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections.

What are the estimated completion date and expected results of the clinical trial?

The estimated study completion date is June 2024, with headline results from the clinical trial expected to be reported in 2H 2024.

Why is the study significant?

Infectious diarrhea is a common illness among travelers and US troops deployed overseas, affecting daily performance, judgment, morale, and operational readiness. The study aims to address the increasing resistance to antibiotics and the post-infectious sequelae associated with traveler's diarrhea.

Who is leading the clinical study?

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.