Excellent news..
TCG
Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US Highlights:
• Immuron proceeding to Phase 3 registration strategy with the FDA
• Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose
• 36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group (primary endpoint)
• 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group (secondary endpoint)
• 83.3% statistically significant reduction in the number of subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo (secondary endpoint)
• 100% of the subjects requiring IV fluids post challenge were in the placebo (secondary endpoint)
• 55.6% reduction in the number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan® group compared to the placebo group (secondary endpoint)
• Phase 2 clinical study data supports the excellent safety and tolerability profile of Travelan®
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- Ann: Travelan to progress to Phase 3 Clinical Trials in the US
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