New York, March 08, 2024 - PRISM MarketView - Australian biotechnology company, Immuron Limited (Nasdaq: IMRN) has announced positive interim topline results from its study of Travelan® in preventing moderate to severe diarrhea following an enterotoxigenic Escherichia coli(ETEC) infection. The study supports the excellent safety and tolerability profile of Travelan®, and demonstrated that a single daily dose offered protective efficacy in healthy subjects challenged with ETEC.
The final clinical study report will be completed in the second half of 2024. Immuron is now working towards an end of Phase 2 meeting with the FDA to discuss the pivotal Phase 3 registration strategy and planned clinical trials to support a Biologics License Application (BLA) for Travelan® as a prophylactic medicine for Travelers’ Diarrhea.
Highlights
Travelan® is a first-in-class, oral antibody therapy. Immuron was awarded AU $4.8 (USD $3.43) million funding by the U.S. Department of Defense (ASX Announcement 12 January 2022) to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries.
The study demonstrated 36.4% protective efficacy against ETEC-induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group, 66.7% protective efficacy against ETEC-induced severe diarrhea was observed in the Travelan® group compared to the placebo group, and an 83.3% reduction in the number of subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo.
100% of the subjects requiring IV fluids post challenge were in the placebo group.
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases. For more information visit: https://www.immuron.com.au/ and https://www.travelan.com
Immuron Limited ia featured on PRISM Emerging Biotech Index
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