Immuron Positive Results Support Travelan® progress to Phase 3
- 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®
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.