Immuron proceeding to Phase 3 trials for Travelan after positive results

Immuron announced 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, or ETEC. Immuron was awarded $3.43M funding by the Department of Defense to perform a phase 2 controlled human infection model study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries. Final clinical study report will be completed in H2 2024. 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. Travelan will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials. This trial demonstrated protective efficacy with once daily dosing even though the attack rate for this study was much lower than planned. The company will now proceed to hold an end of Phase 2 meeting with the FDA to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application for Travelan as a prophylactic medicine for Travelers’ Diarrhea. 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. For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group. Immuron has filed a provisional patent application with the U.S. Patent Office including results from this trial.