A new drug aimed at fighting an infection caused by Clostridium difficile is due to be submitted for approval after passing a milestone in clinical studies.
Clostridium difficile is a recurrent type of infection frequently affecting older individuals in community healthcare and nursing home settings. People with compromised immune systems particularly those with underlying disease are at risk of developing the infection. Recurrence is a major problem, approximately 1 in 4 patients experience recurrence after an initial episode.
Bezlotoxumab is a monoclonal antibody designed 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. The drug was licensed to Merck in 2009 for further development including clinical trials.
The medical experts conducted two studies over a 12-week period to evaluate bezlotoxumab. The first study involved nearly 1,500 patients in 19 countries and the second recruited 1,200 people in 17 countries. The participants were administered either a single one-time infusion of bezlotoxumab alone or bezlotoxumab plus actoxumab, which is used to treat toxin A.
The researchers noted a 15 % reduced risk of C. difficile recurrence among both the group of the study subjects. Moreover, the combined treatment was no more effective than bezlotoxumab alone. Therefore, bezlotoxumab alone was selected for the marketing authorization application.
“We have therapies to treat the initial episode, but this infection come 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,” said Nick Kartsonis, associate vice president in clinical research at Merck.
Clostridium difficile, a spore-forming bacterium, causes inflammation of the large intestine known as pseudomembranous colitis. Toxin B is responsible for causing the infection. Toxin B destroys the intestinal mucosa and causes inflammation. This leads to the symptoms of C. difficile, including abdominal pain and watery diarrhea. IMAGE/gov.uk