- Clostridium difficile (C. difficile) is a difficult-to-treat bacterial infection that affects roughly 500,000 people in the U.S. each year, and contributes to 29,000 deaths.
- In pivotal studies, Merck's investigational bezlotoxumab reduced the risk of C. difficile recurrence from 25% to 15% in infected patients.
- The breakthrough here is the possibility of preventing recurrence of a bacterial infection that frequently recurs and then becomes even more difficult to treat.
Merck tested two antibodies for treatment of C. dificile, including bezlotoxumab and actoxumab. Since actoxumab had no efficacy at all, that arm was stopped.
However, the results with bezlotoxumab have been encouraging enough that Merck is planning to file with the FDA before the end of the year. The real benefit here would be not only preventing recurrence, but possibly decreasing the overall death rate from C. difficile.