Core Insights - Immuron Limited has submitted the Clinical Study Report for its Phase 2 study of Travelan (IMM-124E) to the FDA and plans to request an end of Phase 2 meeting, which is necessary to advance to Phase 3 [1] Group 1: Clinical Study Results - The Phase 2 clinical study demonstrated statistically significant lower levels of IgA and IgG in subjects receiving Travelan compared to the placebo group, indicating reduced exposure to ETEC antigens [2] - There was a statistically significant reduction in the number of colony-forming units (CFUs) in the stools of subjects who received Travelan, measured 48 hours post-challenge (p = 0.0121), suggesting faster clearance of ETEC from the gastrointestinal tract [3] - Participants in the Travelan group exhibited a more stable gastrointestinal microbiota compared to the placebo group, with improved alpha diversity metrics indicating greater richness and evenness of bacterial species [4] Group 2: Microbiome Analysis - Statistically significant differences in beta diversity were observed between the treatment groups, with the Travelan group showing increased levels of beneficial bacteria such as Akkermansia and Faecalibacterium [5] - The data indicated a potential link between the presence of certain bacterial species and reduced inflammation, suggesting that Travelan may aid in the recovery of the gut microbiome [6] Group 3: Ongoing Studies - A field study conducted by the Uniformed Services University has randomized a total of 776 subjects to evaluate a dietary supplement for maintaining gut health during deployment and travel, with follow-up expected to be completed around June 2025 [7]
Immuron Announces Travelan® Clinical Trial Update