Sanofi starts C. diff study
pharmafile | October 28, 2013 | News story | Research and Development, Sales and Marketing | C diff, Sanofi Pasteur, cdi, clostridium
Sanofi’s vaccines division is beginning a Phase III programme looking at the safety and effectiveness of an investigational treatment for Clostridium difficile (C. diff) infection (CDI).
Sanofi Pasteur has just started recruiting volunteers in the UK for the Cdiffense trial, a randomised, placebo-controlled, multi-centre trial that will include up to 15,000 adults in 17 countries.
The spore-forming bacterium causes intestinal problems and has been a high profile disease, not least because the risk of acquiring it increases the more time a patient spends in hospital.
For health authorities it is a problem because it lengthens in-patient stays – with European Union data suggesting that €3 billion is spent each year on CDI acute care.
There are an estimated 500,000 cases of CDI in the US every year, with annual costs to the healthcare system of $3.2 billion.
C. diff is an anaerobic spore-forming bacterium, and is present asymptomatically in approximately 60% of infants but only around 3% of healthy adults.
Infection occurs when the natural microbial flora of the gut are disturbed, usually as a result of antibiotic treatment for other infections, and a patient ingests C. difficile spores.
The bacteria can multiply and release the two toxins which cause a broad range of gastrointestinal symptoms in humans known collectively as CDI.
“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” said Sanofi Pasteur’s senior vice president for R&D, John Shiver.
“Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff,” he added.
The new vaccine is designed to produce an immune response targeting the toxins generated by C. diff bacteria, which can cause inflammation of the gut.
As well as hospital stays, age and antibiotic treatment are other risk factors for the disease, and volunteers for Cdiffense will be 50 or older and planning a hospital stay, or have had at least two stays recently, or had systemic antibiotics in the past year.
Adam Hill
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