Immuron (ASX:IMC) looks toward pivotal Travelan trials

Immuron is looking toward Phase 3 clinical trials after more positive results for Travelan, its over-the-counter immune supplement used to treat traveler’s diarrhea being advanced towards a pivotal registration with the US Food and Drug Administration.

Clinical study data supported an excellent safety and tolerability profile and protective efficacy with a single dose for Travelan, already approved and available for over-the-counter purchase in Australia, the US, and Canada.

Travelan has surpassed the record quarterly sales reported last year, and the planned clinical trials will include recommended dosing to support a Biologics License Application for the prophylactic medicine and greater reach as a licensed drug.

Infectious diarrhea is the most common illness among US troops serving overseas, and a preventative treatment has captured the military’s attention as a high priority objective, with Immuron the beneficiary of a $4.8 million dollar award from the US Department of Defense to evaluate military-strength dosing.

Data has shown a significant protective efficacy against induced severe diarrhea compared to placebo groups and shown an 83.3 per cent reduction in the number of subjects requiring early antibiotic treatment.

All subjects requiring intravenous fluids after the challenge were in the placebo group, but Immuron has noted a lower than intended attack rate among the placebos meant the study was underpowered – making the demonstration of protective efficacy and reduction of adverse effects particularly noteworthy.

The drug will be the first developed with Immuron’s platform technology to proceed to the next stage of pivotal studies, and the biotech company believes its underlying tech will enable development of medicines across a wide range of infectious diseases.

Immuron will now hold an end of Phase 2 meeting with the FDA to discuss the key Phase 3 strategy ahead of the planned clinical trials.

Read Market Open’s feature with Immuron Chief Executive Officer Steven Lydeamore: Traveler’s diarrhea – more than an inconvenience.

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