Immuron says NMRC completes interim analysis for evaluation in Campylobacter

Following discussion with the US Naval Medical Research Command, Immuron can announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli. The results of this clinical trial are unrelated to Travelan and do not impact Immuron’s plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration with a view to initiating Phase 3 clinical trial of Travelan in 2H 2025. Nor does this NMRC trial impact on Immuron’s commercialization strategy for Travelan. This commercialization strategy also includes the results of the Uniformed Services University clinical study of Travelan which is 85% recruited with topline results anticipated in April 2025. The trial was funded by the NMRC. Immuron’s involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study. Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. Relatively little is known regarding what constitutes protective immunity against Campylobacter and there is currently no licensed vaccine to prevent disease caused by C. jejuni. C. jejuni is considered an invasive enteric pathogen, but the molecular details of its pathogenesis remain difficult to interpret or understand largely due to the lack of reliable, non-primate animal models of disease. To address this unmet medical need, the NMRC developed a conjugated vaccine using the Campylobacter jejuni capsule crosslinked to the colonization factor antigen 1 of Enterotoxigenic Escherichia coli. These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and CFA/1. Immuron has been advised by NMRC that the safety and protective efficacy of the product was tested in a controlled human infection-model clinical trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis. A total of 27 volunteers were enrolled in the randomized, placebo-controlled trial and randomly assigned to either the active or placebo arm of the study. The interim results demonstrated 10.4% protective efficacy against moderate to severe campylobacteriosis following challenge with Campylobacter compared to the placebo group. Data analysis by the NRMC continues, including secondary and exploratory endpoints, which may provide insights as to why protective efficacy for CampETEC for was lower than that achieved in similar studies with Travelan. Immuron is not privy to any further details of the study at this time, pending the presentation of findings. Travelan(R) demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. These studies showed dosing 400 mg three times daily, resulted in 76.7% to 90.9% protection and more recently 36.4% protective efficacy in a single daily dose Phase 2 study designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. This Phase 2 single dose trial also produced clinically relevant secondary endpoints. The vaccine used in CampETEC was a conjugated vaccine for both campylobacter and ETEC. The NMRC recently received U.S. Department of Defense funding to develop a new campylobacter vaccine not conjugated with ETEC as well as new vaccines for shigella and different strains of E.coli. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. NRMC and Walter Reed Army Institute of Research are now developing an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrheal pathogens