• 11 Mar 2024
• Admin
• News Article

Immuron Will Proceed with Phase 3 Trials Post Topline Results

Immuron announces interim topline results from Travelan; to proceed to phase 3 clinical trials in US

Overview

Immuron Limited, an Australian-based and globally integrated biopharmaceutical company, has announced the interim topline results confirming that a single daily dose of Travelan is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

Overview of Study

• This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. 
• Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.

Change in Dosing

Having demonstrated protective efficacy in two published clinical studies, this phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing.

Efficacy & Safety

• This trial demonstrated protective efficacy with once daily dosing even though the attack rate for this study was much lower than planned. 
• The intended attack rate (percentage of subjects with ETEC-induced moderate- severe diarrhea) for this study was approximately 70%. 
• The attack rate for the Placebo group of this study was only 37%.

Immuron proceeding to phase 3 registration strategy with the US FDA.

Travelan Topline Clinical Trial 

• 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).

Future Plans to Prevent Infectious 

• The company will now proceed to hold an end of phase 2 meeting with the US Food and Drug Administration to discuss the pivotal phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine for Travelers’ Diarrhea. 
• A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.

Immuron is in the process of exploring non-dilutive funding opportunities for these phase 3 clinical trials.

About Travelan

Travelan, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo.

Effectiveness of Drug 

• ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan group compared to the placebo group. 
• Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan group compared to the placebo group. 
• Statistically significant reduction of 83.3% in the subjects in the Travelan group requiring early antibiotic treatment post challenge compared to the placebo.

For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan group compared to the Placebo group.

Studies using the CHIM for a variety of different enteric pathogens suggest the greatest protection may be against more severe disease and in studies where the disease appears to be predominately mild, which appears to be the case in this study, the efficacy estimates can be lower than anticipated.