Ann: Immuron Travelers Diarrhea Market Update, page-2

Hello...stirrings lead to news. And here it comes aaahhhh
Immuron Travelers’ Diarrhea Market Update
Key Points
• Immuron’s IMM-124E IND Program recommences
• Uniformed Services University to recommence planned Travelers’ Diarrhea clinical study
• COVID-19 - Consultancy Agreement with Infectious Disease Epidemiologist at Wayne
State University
Melbourne, Australia, October 12, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an
Australian biopharmaceutical company focused on developing and commercialising oral
immunotherapeuticsfor the prevention and treatment of gut mediated pathogens, today is pleased
to provide shareholders and the market with an update on the planned clinical programs in
Travelers’ Diarrhea (TD).
The Board of Immuron has approved company plans to recommence the CMC related activities
regarding its investigational drug IMM-124E required to support an investigational new drug (IND)
application to the FDA and the proposed phase III clinical study in TD.
The company has recently been advised by the Uniformed Services University (USU) that it has
recommenced the planned clinical trial program to evaluate the efficacy of non-antibiotic OTC
products in Travelers’ Diarrhea and will provide a purchase order for IMM-124E. USU’s Infectious
Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel
Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical
products for TD and inform strategies for Force Health Protection. The P4TD study is a randomized,
double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of
3 commercially available nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment
or travel to a high-TD risk region. All study participants (1336 in total) will be randomized to one of
the three active products or placebo (334 per arm).
The company is also pleased to announce that it has executed a consultancy agreement with
Professor Teena Chopra, Professor of Medicine Wayne State University School of Medicine, Detroit
Michigan. Professor Chopra is an Infectious Disease Epidemiologist with a specific interest in
Clostridiodes difficle (C.difficle) infections. Professor Chopra and her team recently published their
research findings on patients at a hospital associated with the Detroit Medical Center presenting
with both SARS-CoV-2 and C.difficle1. Both infections can manifest as digestive symptoms and merit
screening when assessing patients with diarrhea. The hospitals associated with the Detroit Medical
1 https://doi.org/10.3201/eid2609.202126
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Centre treated over 600 patients presenting with COVID-19 during the peak of the pandemic.
Professor Chopra and her team noted most predominantly included pulmonary symptoms but a
small subset of less than 10% of the cases also included gastrointestinal events. Professor Chopra is
building a registry of the patients presenting with gastrointestinal events to better understand this
cohort and the unique medical challengesthey present and will be an invaluable resource to access.