IMC - Immuron Limited

plenty of hop on pop , again
.. $33mill MC.

...coming out of trading halt

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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®

Chart update

Good evening
No posts since 25/03/24

Announcement today (14/01/25) that IMC has submitted the Clinical Study Report to the U.S. Food and Drug Administration for the recently completed Phase 2 study and will soon request and end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3 ... see attached.
Moreover, in brief:

• 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; and
• Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects

Daily
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Kind regards
rcw1