- First cohort of 30 healthy volunteers enrolled in the Travelan® Clinical Trial
- Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military has commenced
- Final 30 participants anticipated to be enrolled and commence the study in October 2023
- Travelan® is known to protect against the onset of Travelers diarrhea (TD), the most common illness reported by travelers
MELBOURNE, Australia, July 25, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the first cohort of 30 participants have been enrolled into the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 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 diarrhea. ClinicalTrials.gov Identifier: NCT05933525.
The first cohort of 30 participants is anticipated to complete dosing and the in-patient stage of the study by the first week of August 2023. The final 30 participants are anticipated to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023. Headline results from the clinical trial expected to be reported in 1H 2024.
The U.S. Department of Defense Uniformed Services University is also running a randomized clinical trial with Travelan® in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783. The USU has reported that to date it has successfully enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study. USU has extended the enrolment period and now expects to complete clinical trial enrolment in Q2 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, travelers' 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.
Chief Executive Officer
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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