Immuron Limited announced the funding of a new research agreement with the U.S Department of Defense. Immuron awarded AUD 4.8 million funding by the U.S. Department of Defense for Travelan U.S Naval Medical Research Center Received AUD 1.4 million funding to support the Travelan clinical development effort. Total Award AUD 6.2 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 USA. 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.