Immuron’s Travelan study results show major leap in digestive health protection, plans Phase 3 trial

Australian biopharmaceutical company Immuron (ASX: IMC) has released interim topline results from a US-based clinical trial of lead candidate IMM-124E (Travelan) confirming that a single daily dose can be effective in the prevention of moderate-to-severe diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

The double-blind, phase 2 controlled human infection model trial aimed to evaluate a dosing regimen to suit US troops deployed to developing countries where they could be at risk of gastrointestinal disorders.

It was designed to compare the preventative effects of once daily dosing to the current standard recommended dosage of three times per day.

Sixty healthy volunteers were recruited to an in-patient challenge within the study and randomly assigned to receive a daily oral dose of 1200 milligrams of Travelan or a placebo.

Dosing commenced two days prior to being exposed to ETEC strain H10407 and continued for seven days.

Positive efficacy

Interim results showed a 36.4% protective efficacy against ETEC-induced moderate-to-severe diarrhea and a 66.7% protective efficacy against severe diarrhea in the Travelan group compared to the placebo group.

There was also a statistically-significant 83.3% reduction in the number of subjects in the Travelan group who required early antibiotic treatment post-challenge compared to the placebo.

All of the participants who required intravenous fluids post-challenge were from the placebo group.

Further trials

Immuron is scheduled to meet with the US Food and Drug Administration to discuss a pivotal phase 3 registration strategy and further clinical trials.

The agenda will include recommended dosing to support a biologics licence application for Travelan as a prophylactic medicine for travellers’ diarrhea.

The company said a preventative treatment that offers a defence against infectious enteric diseases was a high-priority objective for the US military.

Diarrhea is reported to be the leading infectious disease threat to the overall health and preparedness of deployed personnel.

First-in-class therapy

Travelan is a first-in-class oral antibody therapy which reduces the likelihood of a person contracting travellers’ diarrhea, commonly caused by pathogenic bacteria and related toxins.

When taken with meals, the drug binds to the bacteria to prevent colonisation and the pathology associated with digestive tract disorders.

In Australia, Travelan is a listed medication on the Australian register for therapeutic goods and is indicated to reduce the risk of travellers’ diarrhea and minor gastrointestinal disorders.

In Canada, the drug is a licensed natural health product with the same indications, while in the US it is sold as a dietary supplement for digestive tract protection.