Merck antibody leads to reduced risk of Clostridium difficile recurrence

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.

Bezlotoxumab is a monoclonal antibody created to neutralize C.difficile toxin B. The newly manufactured product is based on the discoveries made at the University of Massachusetts Medical School (UMMS) MassBiologis in cooperation with American biotechnology company Medarex.

Bezlotoxumab is designed to block the ability of a toxin to bind to cells and thus reduces the risk of C. difficile infection recurrence by 15 percent.

Based on these data, the company plans to submit regulatory applications for bezlotoxumab alone in the USA , European Union and Canada later this year. 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.

Furthermore, Loyola University (Chicago) Stritch School of Medicine professor of medicine, Dr. Dale Gerding comments, “Recurrence is a major challenge with C. difficile infection, and novel approaches are needed to help prevent the cycle of C. difficile recurrence”.

Results from the studies were presented for the first time at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and worldwide Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego. Merck said the actoxumab arm was stopped for efficacy and safety reasons after an interim analysis.

The double-blind studies were labeled as MODIFY I and MODIFY II.

One of the symptoms of a Clostridium difficile infection is diarrhea, which when severe enough can lead to death. The recurrence among patients with placebo was 25%.

The drug’s side effects include nausea, diarrhea and urinary tract infection, which occurred at similar rates for patients in the study’s placebo group.

However, bezlotoxumab when used in combination with actoxumab did not demonstrate any added efficacy over bezlotoxumab alone.

Merck & Co. has just announced last Sunday the results from clinical trials involving an antibody that prevents Clostridium difficile from returning, Reuters reported.

In the United States this bacterium, the C.difficile, infects about half a million people each year and causes about 29000 deaths. The research discovered that the an infection recurred in about 25 p.c of sufferers handled with antibiotics and a placebo. The first involved 1,452 patients in 19 countries, with a median age of 65 years.

Therefore, bezlotoxumab alone was selected for the marketing authorization application.