• Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA
• Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Immunology Results
• Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Microbiome Responses
• Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects

Immuron Limited, an Australian biopharmaceutical company, has announced that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study of Travelan® (IMM-124E) and will soon request an end of Phase 2 meeting, which is a precursor to proceeding to Phase 3. The Travelan® (IMM-124E) Phase 2 Clinical Study (NCT05933525) was a Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC). The study results showed statistically significant lower levels of IgA and IgG for the subjects who received Travelan® compared to those who received the placebo, which may reflect reduced exposure to ETEC antigen. The clinical data also demonstrated a statistically significant reduction in the number of colony forming units (CFUs) in the stools of subjects who received Travelan®, indicating faster clearance of the challenge strain from the gastrointestinal tract. Additionally, the study found that participants in the Travelan® group had a more stable gastrointestinal microbiota, with improved richness and Shannon diversity compared to the Placebo group. The company also provided an update on the Uniformed Services University field study (NCT04605783), a Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate a Dietary Supplement to Maintain Gut Health During Deployment and Travel, where 776 subjects have been randomized, with the last enrollments expected in March 2025 and follow-up to be completed around June 2025.