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Immuron Ltd (ASX:IMC) has moved through a series of development milestones for its drug Travelan: which aims at preventing contraction of traveller’s diarrhea, a disorder of the digestive tract caused by pathogenic bacteria.
The company on Tuesday told investors it had submitted a Clinical Study Report to the US Food and Drug Administration (FDA) for the recently completed Phase Two study on the drug, aiming to progress to Phase Three once an ‘end of Phase Two’ meeting is arranged.
The Phase Two study was a randomised, double-blind, placebo-controlled trial that sought to find out the efficacy of Travelan (IMM124E) in a controlled human infection model for Enterotoxigenic Escherichia Coli (ETEC).
According to the function of Travelan, the drug’s antibodies target and bind to ETEC antigen in the gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers.
And, indeed, subjects treated with the drug showed statistically lower levels of immunoglobins IgA and IgG compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen.
Data from the trial also showed a statistically significant reduction in the number of colony
forming units (CFUs) in the stools of subjects who received the drug, indicating faster clearance of the challenge strain.
Other beneficial indicators from the trial included the observation that participants in the Travelan group had a more stable gastrointestinal microbiota over the treatment period when compared with the placebo group, as well as increased levels of beneficial bacteria like Akkermansia and Faecalibacterium.
Immuron shares have shifted upwards on the news, and at 15:55 AEDT, they were trading at 9.9 cents – a rise of 15.12% since the market opened.
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