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CDI is an infection of the colon caused by the bacteria Clostridium difficile. It is characterised by severe diarrhoea but can also result in serious disease complications including bowel perforation, toxic megacolon and sepsis. It can prove fatal in the most severe cases.
>1m Cases per year in the US and Europe.
~$4.8bn  Annual acute care costs with ~29,000 deaths per year in the US.
~25%  Recurrence is the primary clinical issue in CDI as up to 25% of CDI patients have a second episode; the risk of recurrence rises to 65% after a third episode.
CDI is a serious issue in North America and Europe with estimates of more than one million cases of CDI per year in the US and Europe. The US Centers for Disease Control and Prevention (‘CDC’) reports that CDI is responsible for 29,000 deaths per year in the US. The CDC has also designated C. difficile as one of three pathogens that poses an immediate public health threat and requires urgent and aggressive action.
A healthy and diverse microbiome naturally protects against C. difficile colonisation and infection. Patients who contract CDI typically have damaged microbiomes due to prior broad spectrum antibiotic treatments for an unrelated infection. Initial treatment with the current standard of care antibiotic, vancomycin, fails to sustain cures in approximately one third of cases due to further damage that vancomycin causes to patients’ microbiomes. The use of vancomycin leads to a high risk of recurrent disease. The risk of further recurrence rises to 65% after a patient suffers a second episode of CDI. Each recurrent episode of CDI is typically more severe than the prior episode and carries an increased risk of mortality. Reducing recurrent CDI is the key clinical issue.Ridinilazole is our Phase 3-ready, precision antibiotic in development for front-line CDI treatment to cure the initial infection and reduce disease recurrence. It exemplifies our strategy combining new science and philosophy to create new opportunities.

New Science

Ridinilazole is a new mechanism antibiotic. It is highly selective for C. difficile and works to kill the bacteria by stopping cell division.

In a Phase 2 clinical trial called CoDIFy, this selectivity allowed ridinilazole to outperform vancomycin by killing C. difficile while preserving patients’ microbiomes to reduce disease recurrence. Ridinilazole achieved statistical superiority over vancomycin in sustained clinical response (‘SCR’), which captures ridinilazole’s impact on both the initial treatment and disease recurrence.

Ridinilazole has been generally well tolerated in Phase 1 and 2 clinical trials.

New Philosophy

With these positive results, we are advancing ridinilazole to Phase 3 clinical trials to support the right label for treating CDI and reducing recurrences. To do so, we have designed the Phase 3 trials to test for superiority over the standard of care, vancomycin, in SCR, which was achieved in CoDIFy. Further, we are gathering health economic outcomes data that we believe will be important to support the commercialisation of ridinilazole, if approved. The Phase 3 clinical trials are expected to begin in the first quarter of 2019.

For more information on this study, you may go to the ClinicalTrials.gov website.  If you have further questions or are interested in participating, please Contact Us.

Meet the Doctors


Christina L. Errichiello


Michael J. DiGiovanna


Dr. Omer K. Masood, M.D.