The US Defence Department is to lodge an investigational new drug (IND) application with the Food and Drug Administration to press on with studies of Immuron’s novel treatment of gut pathogens.
The DoD Naval Medical Research Centre (NMRC) has requested a meeting with the FDA for guidance on Phase 2 trials of the Melbourne drug developer’s drug to prevent acute infectious diarrhea.
Immuron is commercialising its Travelan preventative treatment for campylobacter and ETEC (E-Coli) infections in association with NMRC.
However the Covid-19 pandemic has derailed FDA work on all but Covid-related drugs and those tackling life-threatening conditions.
Immuron told investors the NMRC planned to move on to Phae 2 clinical trials during the first half of 2021 following the FDA meeting.
Immuron CEO said: “I am pleased to say with the easing of restrictions around Australia work on the development of the clinical product can now recommence.
“The plan is to have the product completed by the end of this year and have it ready for clinical evaluation next year.”
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