Monoclonal Antibodies may Be New Treatment for C. Difficile Infection

A recently completed clinical trial has demonstrated that a combination of two fully human monoclonal antibodies, when administered with standard antibiotics, significantly reduced the recurrence of C difficile-related diarrhea.

C difficile

-related diarrhea.

C. difficile

. Results of the clinical trial showed that recurrence rates of diarrhea, which are caused by the

C. difficile

MassBiologics (MBL), of the University of Massachusetts Medical School, and Medarex, a wholly owned subsidiary of Bristol-Myers Squibb

toxins, were reduced by 72% in patients given both the antibiotics and the antibodies. Among patients who received both treatments, only 7% suffered from a recurrence, while 25% of patients who received the placebo suffered from one. The monoclonal antibodies were developed by .

The antibodies were developed to neutralize the toxins A and B that are produced by

C. difficile

randomized, double blind, placebo-controlled Phase II trial. One group of 101 participants received a single injection of the two antibodies, whereas the second group of 99 participants was given a placebo. Both groups were also given standard-of-care antibiotic treatments for CDI. Patients were followed for almost three months, or 84 days, while the researchers observed who suffered from a recurrence.

infection (CDI) in aAccording to a

New England Journal of Medicine

mean duration of the initial hospitalization for inpatients did not differ significantly between the antibody and placebo groups (9.5 and 9.4 days, respectively).” In addition, according to the article, “at least one serious adverse event was reported by 18 patients in the antibody group and by 28 patients in the placebo group (

article on the study, “

P

=0.09).”

The researchers enrolled 200 patients with

“We are pleased that this new treatment had such a significant impact for these patients,” said senior author Donna Ambrosino, MD, executive director of MassBiologics, professor of pediatrics. “This disease is a growing public health problem and the need for effective treatment options is quite clear. The team at MBL is gratified that we have been able to discover effective antibodies, and then translate the discovery to a product with the collaboration of our colleagues at Medarex.”

A recently completed clinical trial has demonstrated that a combination of two fully human monoclonal antibodies, when administered with standard antibiotics, significantly reduced the recurrence of