IMRN - Immuron adds 47% as FDA clears clinical trial for infectious diarrhea candidate

Australian biotech Immuron Limited ( NASDAQ: IMRN ) gained ~47% pre-market Friday after announcing that the FDA greenlighted its Investigational New Drug (IND) application to study OTC medicine Travelan as a treatment to prevent infectious diarrhea.

Accordingly, Immuron ( IMRN ), the sponsor of the IND, plans to run a U.S.-based study to evaluate the potential of a single-dose regimen of Travelan in the prevention of infectious diarrhea caused by enterotoxigenic Escherichia coli.

The trial conducted by contract research organization Pharmaron CPC at a clinical research facility in Baltimore, Maryland, will involve up to 60 healthy adult volunteers who will receive a once-daily Travelan or placebo randomly.

The study is expected to start in H1 2023, with headline data anticipated by the end of 2023.

Infectious diarrhea is the most prevalent illness reported by travelers to developing countries and overseas-based U.S. troops. The need for a more suitable dosing regimen of Travelan for U.S. military will be considered in the study.

Travelan, indicated as an over-the-counter medication to cut risk of travelers’ diarrhea, generated $0.6M in sales in FY22 from North America.

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