Merck & Co Inc. developed an antibody that was proven to reduce the risk of getting infected with the Clostridium difficile bacterium by ten percent.
Each year, nearly half a million people are infected with the Clostridium difficile, and about 29,000 people die from the infection. Standard antibiotics are used in order to treat the infection, but they also kill other good bacteria (probiotics) that reside naturally in the human body and that keep the Clostridium difficile under control.
Sunday, Merck presented two Phase 3 studies at the medical meeting in San Diego. The studies showed that by following a two-week treatment with antibiotics and by taking one bezlotoxumab, a human monoclonal antibody, the risk of getting infected with the Clostridium difficile would be reduced by 15 percent. The infection appeared again in 25 percent of the patients who were treated only with a placebo and antibiotics, according to the study.
“We have therapists to treat the initial episode, but the 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,” stated Nick Kartsonis, an associate vice president in clinical research of antibacterials, antifungals, HIV and CMV at Merck.
The company hopes that the bezlotoxumab, licensed from the Medarex and Massachusetts Biologic Laboratories which is now owned by Bristol-Myers Squibb, will receive regulatory approval by the end of the year.
The side effects of both the patients who received the treatment, as well as for those who got the placebo were similar and included: diarrhoea, nausea, urinary tract infection, etc.
Over the past two decades, the Clostridium difficile infections have risen drastically. According to the U.S. Centres for Disease Control and Prevention, the infections are now the number one infection that is acquired through the United States healthcare in community hospitals. Companies are now working on developing vaccines against Clostridium difficile.
A common treatment that doctors use is the stool transplant. With the help of this procedure, the balance of friendly bacteria is restored in the gastrointestinal tract of a patient who suffers from severe cases of diarrhoea.
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