Immuron Limited announced the interim topline results confirming that a single daily dose of Travelan is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC). Immuron was awarded USD 4.8 million funding by the U.S. Department of Defense to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries. This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study.

Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024. Having demonstrated protective efficacy in two published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. IMM-124E (Travelan) will be the first product developed with Immuron's platform technology to proceed into Phase 3 clinical trials.

The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious diseases. This makes the demonstration of protective efficacy and reduction in adverse events and diarrhea particularly noteworthy. The company will now proceed to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine for Travelers' Diarrhea.

A preventative treatment that defends against infectious enteric diseases is a high priority objective for the U.S. Military. Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials. Topline results: Travelan, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo.

ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan group compared to the placebo group; Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate; 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan Group compared to the placebo group; Statistically significant reduction of 83.3% in the subjects in the Travelan groups requiring early antibody treatment post challenge compared to the placebo group; For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group; 55.6% reduction in the number of subjects experiencing adverse events and diarrhea. 55.6% reduction in The number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan group compared to the randomized double-blind placebo group; 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan group compared to the Placebo group.