The FDA has removed a clinical hold on Immuron's (IMC: $0.08) study for a new therapeutic to prevent infectious diarrhea, caused by two bacteria, E. coli and Campylobacter.

The product was developed by the US Navy (Naval Medical Research Center), with the NMRC having made the vaccine conjugate against the two bacteria and produced by Immuron from vaccinating cows and harvesting the polyclonal antibodies from colostrum, similar to with its Travelan product. Travelan is produced from two vaccines given to cows that is effective against 13 strains of E.coli.

This is the third clinical study using Immuron's technology that is being funded by the US Department of Defense. The other two studies are trialing Travelan at high doses, with the first being given to soldiers entering high risk areas to guard against diarrhea from E.coli infection (study underway), and the second a controlled study in volunteers given E.coli (study due to begin).

The NMRC study which has now been cleared will involve two parts, one where volunteers will receive Campylobacter and the other volunteers will receive E.coli. Comparison against placebo will be assessed. Top line results from both parts are expected in 1H 2024. Each part will involve 30 volunteers.

Immuron CEO Steven Lydeamore was confident that any safety concerns raised by the FDA would be cleared given its products are not absorbed into the blood stream. By the middle of next year, Immuron should have results from three clinical studies.

Immuron is capitalised at $18 million with $18.5 million in cash at the end of last year.

Bioshares recommendation: Speculative Buy Class A

Immuron has been added to the Bioshares Model Portfolio.

CEO Steve Lydeamore will be presenting at this year's Bioshares Biotech Summit in Hobart in July.