Pharmaceutical giant Merck & Co. will seek approval this year for the first treatment to prevent the recurrence of a highly common hospital-acquired bacterial infection.
The drugmaker recently announced successful completion of two Phase 3 clinical trials of its experimental drug bezlotoxumab, a monoclonal antibody that targets the toxin in the stomach that causes Clostridium difficile, an infection in the digestive tract that occurred in about 453,000 patients, according to a New England Journal of Medicine study.
The company stated the drug was found to reduce C. difficile recurrence over 21 weeks compared with a placebo, when it was used in conjunction with standard antibiotics.
"These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence,” Dr. Mark Wilcox, a lead investigator for the studies, said in a released statement.
More than 2,600 patients took part in the two trials, which spanned more than a dozen countries. Results found that recurrence of C. difficile for those who took bezolotoxumab was 17%, compared with 28% for patients who took a placebo.
Increase in the number of cases of the infection over the past two decades has been linked with the overuse of antibiotics. The NEJM study found up to 66% of C. difficile infections were associated with being in a healthcare setting, although only 24% were found to have been contracted during a hospital stay, suggesting the highest risk for infection may occur upon discharge.
C. difficle has become the most common healthcare-acquired infection, costing up to $4.8 billion annually in health costs, according to the Centers for Disease Control and Prevention.
The infection and others in its class are also the motivating factor in a nationwide campaign to address antibiotic resistant diseases.
Everyone from the White House to providers have started initiatives to raise awareness and standards to correctly prescribe antibiotics and to curb the spread of infection.