Immuron Receives A$6.2 Million Award from U.S. DoD to Clinically Evaluate a Military Strength Dosing Regimen for Travelan

Key Highlights:

• Immuron Awarded AU $4.8 (USD $3.43) million funding by the U.S. Department of Defense for Travelan
• U.S Naval Medical Research Center Received AU $1.4 (USD $1.02) million funding to support the Travelan clinical development effort
• Total Award AU $6.2 (USD $4.45) million to examine a dosing regimen for Travelan more suited for use by the military
• Plans in place to conduct a controlled human infection model (CHIM) clinical trial in 60 healthy volunteers in the US

MELBOURNE, Australia, Jan. 12, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, is pleased to announce the funding of a new research agreement with the U.S Department of Defense.

The focus of this new agreement, entitled “Biologics License Application (BLA) of a therapeutic Bovine Immunoglobulin supplement targeting Travelers’ Diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC)”, is aimed at testing and confirming the efficacy of a single larger dose regimen of Travelan® in a controlled human infection model (CHIM) clinical study using the enterotoxigenic Escherichia coli (ETEC) strain H10407. This single larger dosing regime is potentially more amenable for use in military populations. Up to 60 volunteers will be enrolled in the clinical study and will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® or placebo. This study will occur across two cohorts (n=15 Travelan® subjects and n=15 placebo subjects per cohort), as the inpatient unit can accommodate up to 30 study participants at a time. Results of the proposed clinical study will also inform on dosing in the pivotal Phase 3 registration trials for BLA licensure. A project kickoff meeting for this award has been scheduled for the end of January with the U.S Government sponsors.

The proposed development program is based on the past commercial and clinical trial experience with Travelan®. Two company sponsored clinical studies have demonstrated that Travelan® conferred 84% to over 90% protective efficacy against moderate to severe diarrhea upon challenge with ETEC in comparison to a placebo. These clinical studies were performed using two different doses of Travelan® (200 mg and 400 mg), administered three times a day. Ongoing discussions with Army and Navy leadership have highlighted that such a regimen is cumbersome for military personnel deployed in austere environments and military field studies have shown that compliance is low with products dosed more than once per day.

“This new project expands our clinical development program and represents the first of several significant clinical trials which the Company expects to undertake with the US Military in 2022. The NMRC also plans to clinically evaluate the protective efficacy of our new oral therapeutic targeting Campylobacter and ETEC this year in two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis, and the second trial focusing on ETEC infections,” said Dr. Jerry Kanellos, CEO of Immuron. “The new funding is testament to the value proposition our hyperimmune bovine polyclonal colostrum technology offers to benefit the US Military as well as the civilian international travelling population.”

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 lowers operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have an 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 and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases, is a high priority objective for the US Military.

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

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 infectious diseases.

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