Immuron Limited announced that it has approved proceeding with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND submission. IMM-529 was developed for treatment of Clostridioides difficile (C. difficile) which is an anaerobic, spore-forming, gram-positive bacillus typically associated with gastrointestinal disease. Transmission of C. difficile occurs by infection of spores either through person-to-person contact, animal-to-person contact or environment-to-person contact.

C. difficile infection (CDI) can cause life-threatening diarrhoea and is the leading healthcare-related gastrointestinal infection in the world. Lumanity, a leading lifescience consulting company conducted an opportunity assessment of IMM-529. Infectious disease experts react favourably to the IMM-529 mechanism of action, and its unique ability to target three elements of the CDI infection -- the spores, vegetative cells, and Toxin B. Base case yearly revenue in USA for IMM- 529 was estimated at USD 92 million for the target patient population (limited to second recurrence and later).

Positioning IMM-529 earlier than second recurrence could lead to higher uptake. The global CDI market was estimated to increase to $1.7B by 2026, according to a report by GlobalData. Pharmaron have scheduled 96 telehealth screening interviews since recruitment for the planned Travelan clinical study was initiated at the end of May 2023.

To date 81 potential candidates have been selected for in-person screening visits which are anticipated to commence on the 28 June 2023 at Pharmaron's Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan(R) compared to a placebo in a controlled human infection model (CHIM) in up to 60 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years.