Merck & Co. has just announced last Sunday the results from clinical trials involving an antibody that prevents Clostridium difficile from returning, Reuters reported.
The results of the studies involving the antibody bezlotoxumab were presented at the annual International Conference on Antimicrobials and Chemotherapy and the International Congress of Chemotherapy held in San Diego from Sept. 17 to 21.
According to Merck & Co., the Phase III studies of bezlotoxumab found that giving it as a one-time infusion, along with 12 weeks of standard course of antibiotics for C. difficile, reduced the risk of recurrence of the bacteria by 15 percent.
On the other hand, 25 percent of patients who were given antibiotics and a placebo treatment experienced a recurrence of the infection.
Bezlotoxumab is not classified as antibiotics, but rather a human monoclonal antibody that attacks the toxin produced by C. difficile. The toxin is responsible for the inflammation of the gut lining, which then results to C. difficile enteritis characterized by watery diarrhea and abdominal pain.
The antibody was developed by University of Massachusetts Medical School researchers, together with Medarex, which is now under the ownership of Bristol-Myers Squibb. Merck & Co. obtained the license to the antibody in 2009 as a potential treatment for C. difficile infection.
In the United States alone, C. difficile sickens almost 500,000 people every year and has caused 29,000 deaths.
Currently, antibiotics are the first choice of treatment for the infection, but giving them can also harm the natural beneficial bacteria in the gut that usually maintain harmless C. difficile population.
The U.S. Centers for Disease Control and Prevention reports that cases of C. difficile infection has spiked over the past 20 years.
Based on the latest findings, Merck & Co. is planning to file for a regulatory approval of the antibody by the end of 2015, reports stated.
