A new treatment aimed at fighting Clostridium difficile (C. difficile), an infection that frequently affects older people, has passed a milestone in clinical studies and is now due to be submitted for approval.
Researchers set out to test the antibody bezlotoxumab. According to Merck, the pharmaceutical company with the licence to develop it, bezlotoxumab was designed to neutralize toxin Bâa toxin that causes C. difficile. Toxin B damages the intestinal wall and causes severe inflammation. This can lead to symptoms of C. difficile, including diarrhea and abdominal pain.
Two studies were carried out in hospitals and outpatient sites to analyze bezlotoxumab. The first study involved 1,452 patients in 19 countries, with an average age of 65. The second study focused on 1,203 patients with an average age of 67, across 17 countries.
Each patient was either given a one-time infusion of bezlotoxumab on its own, a placebo or bezlotoxumab plus actoxumabâa monoclonal antibody for treating C. difficile toxin A.
According to Merck, the pharmaceutical company licensed to develop bezlotoxumab, when bezlotoxumab on its own or the bezlotoxumab-actoxumab combo was taken, the infection recurrence was lower compared to the placebo. The benefit was confirmed over a three-month period. Actoxumab didnât provide a benefit when compared to the placebo and the bezlotoxumab-actoxumab treatment combo wasnât more effective then bezlotoxumab on its own.
Therefore, bezlotoxumab alone was selected for the marketing authorization application. The application will be submitted in 2015 and will seek regulatory approval for the antibody in the U.S., Europe, and Canada.
As a result, bezlotoxumab was chosen for the marketing authorization application. The application will be submitted this year and will seek regulatory approval for the antibody in Europe and across North America.
The elderly and people with weakened immune systems are mainly affected by C. difficile. Approximately one in four patients experience recurrence of the infection after the initial occurrence and 40% go on to have further recurrences.
Source for Todayâs Article:
Brazier, Y., âNew antibody offers hope in fight against C. difficile infection,â Medical News Today web site, September 21, 2015; http://www.medicalnewstoday.com/articles/299764.php.