GlobeNewswire Inc | Oct 12, 2020 06:00AM EDT

October 12, 2020

Key Points

-- Immurons IMM-124E IND Program recommences -- Uniformed Services University to recommence planned Travelers Diarrhea clinical study -- COVID-19 - Consultancy Agreement with Infectious Disease Epidemiologistat Wayne State University

MELBOURNE, Australia, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for 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. USUs 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 IMM-124E (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 Medicineat Wayne State University School of Medicinein Detroit, Michigan. Professor Chopra is an Infectious Disease Epidemiologist with a specific interest in Clostridioidesdifficile (C.difficile) 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.difficile1. Both infections can manifest as digestive symptoms and merit screening when assessing patients with diarrhea. The hospitals associated with the Detroit Medical Center treated over 600 patients presenting with COVID-19 during the peak of the pandemic. Professor Chopra and her team noted that most cases 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 challenges they present, and will be an invaluable resource to access.

__________________________________1 https://doi.org/10.3201/eid2609.202126

C. difficile infection (CDI) is a challenging disease, with a recurrence rate of 15%20% and a mortality rate of 5%. When CDI is present as a co-infection with COVID-19, CDI therapy can be difficult to monitor if diarrhea persists because of COVID-19. Our most recent research findings highlight the importance of judicious use of antibiotics for potential secondary bacterial infection in patients with COVID-19. Antibiotics are known to have unintended consequences, such as C. difficile infection. We recently identified 9 patients in our study who were elderly, an age group at higher risk for complications from overuse of antibiotics, such as adverse events, antibiotic resistance, and concomitant infections like CDI. Immurons technology platform is intriguing because it potentially offers a non-antibiotic solution to this debilitating disease, said Professor Chopra.

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

COMPANY CONTACTDr Jerry Kanellos, Ph.D.Chief Executive OfficerPh: +61 (0)3 9824 5254info@immuron.com

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