Highlights:
- Second cohort of 34 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 the second cohort
- The clinical study 6 month follow up of Cohorts 1 and 2 anticipated to be completed in April 2024
- Travelan® is known to protect against the onset of Traveler’s diarrhea (TD), the most common illness reported by travelers
MELBOURNE, Australia, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce the second cohort of 34 participants have commenced 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 in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan® or placebo. The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial are anticipated to be reported in June 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 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
