XBiotech has launched a research and development (R&D) program to develop an oral monoclonal antibody against Clostridium difficile (C. difficile) infection.
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The company is using its True Human technology for the program. It has started screening human blood samples from donors to detect and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection.
C. difficile infection occurs mostly in patients who recently took various antibiotics or other medications.
The incidence of C. difficile infection has increased rapidly in the last twenty years. XBiotech said it is higher in several patient populations, including people 65 years of age or older, and in patients with compromised immune systems because of an underlying disease or from treatment.
C. difficile is said to have caused about half a million infections in the US in 2011, with 29,000 deaths, often occurring within 30 days of first diagnosis, according to the US Centers for Disease Control and Prevention.
Eight out of 10 deaths related to C. difficile infection in the US occur in patients 65 years of age or older, where recurrent infections are common.
Commenting on the R&D program, Xbiotech president and CEO John Simard said: "This program represents more than the addition of a new anti-infective product to our development pipeline.
"A successful True Human candidate could be the first oral monoclonal antibody against C. difficile, and a model for an oral antibody therapy approach. Recent outbreaks and increased virulence of C. difficile suggest the urgent need to identify novel approaches to treat the disease."