The Board of Directors of Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has given the green light for the company to proceed with IMM-529 cGMP manufacturing for the treatment of a form of gastrointestinal disease.
Directors have also approved the company proceeding with an FDA pre-IND submission for IMM-529, which was developed for the treatment of Clostridioides difficile (C. difficile), an anaerobic, spore-forming, gram-positive bacillus typically associated with gastrointestinal disease.
Transmission of C. difficile occurs by ingestion of spores 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.
Opportunity assessment
Lifescience consulting company Lumanity has conducted an opportunity assessment of IMM-529, which provides encouragement for Immuron.
Infectious disease experts reacted 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.
The base case yearly revenue in USA for IMM529 was estimated at US$92 million for the target patient population (limited to second recurrence and later).
Lumanity said positioning IMM-529 earlier than second recurrence could lead to higher uptake.
The global CDI market is estimated to increase to US$1.7 billion by 2026, according to a report by GlobalData.
Travelan® clinical trial
Meantime, Immuron is also progressing with recruitment and screening for the planned Travelan® Controlled Human Infection Model (CHIM) Clinical Trial.
Pharmaron has 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 June 28, 2023, at Pharmaron’s Clinical Research Facility Inpatient Unit in Baltimore, Maryland US.
The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan® 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.
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travellers’ diarrhea, a digestive tract disorder commonly caused by pathogenic bacteria and the toxins they produce.
Travelan® is a highly purified tabletized preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travellers’ diarrhea.
In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods and is indicated to reduce the risk of Travellers’ Diarrhea, reduce the risk of minor gastrointestinal disorders and is antimicrobial.
In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travellers’ Diarrhea while in the US, Travelan® is sold as a dietary supplement for digestive tract protection.