C. difficile bacteria are found in the environment, including the human gut and in faeces. Many strains of C. difficile produce toxins that cause infectious disease by attacking the gut lining resulting in diarrhoea, abdominal pain, fever and nausea known as C. difficile infections (CDI). Spores from toxic strains of C. difficile bacteria from those infected can rapidly spread to other patients in hospitals and care homes. C. difficile infections causes multiple diarrhoea events per day, which results in severe health implications, including a high hospital mortality rate of up to 25% in frail, elderly people. Current standard of care does not control recurrence. The use of antibiotics, (for example), generic vancomycin as a first line therapy disrupts the patients’ microbiome and enables toxic forms of C. difficile to flourish, causing CDI.
C. difficile infections are a leading cause of hospital acquired infection in the US and EU and current antibiotic treatments lead to recurrence of CDI. There are approximately 500,000 cases of CDI within the US each year and approximately 25% of these initial cases then recur within 1 to 3 weeks of completing an antibiotic course, resulting in around 29,000 deaths in the US per year alone. The cost to the US healthcare system is a significant burden, costing ~ $6 billion each year. CDI is not only a US issue, and it is estimated that there are a similar number of CDI cases in Europe.
Retreatment of recurrent CDI infections is often done with the same or alternative antibiotic which often leads to further CDI recurrence, (a vicious cycle of re-infection). Faecal microbiota transplant (FMT) is an alternative therapy, which does not have regulatory approval and safety risks have been identified, including transmission of infectious agents (E. coli, COVID-19) resulting in FMT associated deaths.
The total annual cost of CDI in the US alone was estimated at $6.3 billion in 2016, with a total annual CDI hospital management required nearly 2.4 million days of inpatient stay with costs of care in US per CDI patient ranging from $10,000 to $20,000. The global C. difficile market has been estimated to be up to $1.7bn by 2026 and NTCD-M3 has a significant opportunity that could deliver global peak sales of above $0.5 billion.