Close to half a million people suffer with C. difficile infection every year causing 29,000 deaths in the United States. Merck & Co Inc, the international pharmaceutical company, has found 15% reduced risk of recurrence of Clostridium difficile (C.difficile) infection in about 12 weeks, in their recent clinically conducted Phase-3 study. In the past two decades, U.S. Centers for Disease Control and Prevention saw steep increase in the infection rate caused by C.difficile.
Standard antibiotics are usually used to treat C.difficile infection, which also kills friendly bacteria that keep C. difficile in control. The new experimental antibody developed by Merck, bezlotoxumab, has been designed specifically to block the ability of a toxin to bind to cells. Merck & Co Inc has also developed another experimental antibody, actoxumab, which showed no benefits when treated alone or in combination with bezlotoxumab.
Company is now planning to seek regulatory approval of the monoclonal antibody in the United States, the European Union and Canada in 2015, after seeing successful results from bezlotoxumab. The company got the license for using bezlotoxumab in development as a potential therapeutic for C.difficile infection in 2009. It has been reported that currently there are no therapies approved for the prevention of recurrent disease caused by C. difficile.
Along with this, few other companies are conducting hardcore research to develop vaccines to treat C. difficile. In addition, doctors are working on techniques like ‘stool transplants’, in which fecal material of healthy patients is inserted into gut of patient with severe diarrhea with an aim to restore friendly bacteria.
Merck associate vice president in clinical research, Nick Kartsonis explains that they have therapies to treat the initial episode but, this infection comes back frequently; there is a 25 percent risk of recurrence after the first time, and that rises to 40 percent or even 60 percent after the second infection.
Dr. Mark Wilcox, of the Leeds Teaching Hospital and the University of Leeds, lead study author claims that results of these studies showed that a single, one-time infusion of the antitoxin bezlotoxumab given with standard of care C. difficile antibiotic treatment significantly reduced the recurrence of C. difficile infection compared to standard of care alone, and demonstrated this benefit over a 12-week period. These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence.
Jorge Santana
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