Immuron Limited, an Australian biopharmaceutical company, has reported encouraging interim topline results from its Phase 2 clinical trial of Travelan®, aimed at preventing diarrhea caused by Enterotoxigenic Escherichia coli (ETEC). The study demonstrated a 36.4% protective efficacy against ETEC-induced moderate to severe diarrhea in the Travelan® group compared to the placebo group. Additionally, a 66.7% protective efficacy was observed against severe diarrhea, and an 83.3% reduction in subjects requiring early antibiotic treatment post-challenge was noted in the Travelan® group.
The trial, which involved 60 healthy volunteers, assessed the efficacy of a single daily oral dose of 1200 mg of Travelan® against ETEC strain H10407. The dosing commenced two days prior to the challenge and continued for seven days. Despite a lower than planned attack rate, the study highlighted the potential of once-daily dosing of Travelan®, showing it to be approximately 50% as effective as the current recommended three times daily dosing regimen.
Immuron is now preparing for an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials. The company is also exploring non-dilutive funding opportunities for these Phase 3 clinical trials. Travelan®, a first-in-class oral antibody therapy, aims to offer a prophylactic solution for Travelers’ Diarrhea, a high priority for the U.S. Military.
The study's results underscore the excellent safety and tolerability profile of Travelan®, with a 55.6% reduction in adverse events observed in the Travelan® group compared to the placebo group. Immuron has filed a provisional patent application with the U.S. Patent Office, including results from this trial, marking a significant step forward in the development of treatments for infectious enteric diseases.
