A multinational, double-blind, placebo-controlled phase 2b study conducted at 84 sites in Europe and North America has demonstrated the ability of ribaxamase to reduce the risk of opportunistic Clostridium difficile
infections (CDI) in hospital patients. The findings from researchers at Synthetic Biologics, Inc., Rockville, Maryland, were presented today at IDWeek 2017 being held in San Diego, California.
“Ribaxamase reduced the incidence of new target CDI by 71% as compared with placebo, protected the diversity of the gut microbiome and reduced the emergence of antibiotic resistance in ceftriaxone-treated patients,” said lead study author John Kokai-Kun, PhD.
The findings are good news. CDI is an “urgent threat," according to Dr. Kokai-Kun. No drugs or vaccines aimed at preventing CDI have been approved by the United States Food and Drug Administration.
CDI produces symptoms that range from diarrhea to colon inflammation that can be life-threatening. About 500,000 Americans fall ill from CDIs every year. More recently, the numbers have been increasing and the symptoms have become more severe and harder to treat. The increased prevalence and severity of the infections coincide with the emergence of a more aggressive strain of C. difficile
that produces more toxins and which can be more antibiotic resistant.
CDI is spread by spores of the bacterium that can persist on surfaces for a prolonged time. They can be transferred to the hands and, if personal hygiene is lax, can be ingested. Toxins produced by the germinated bacteria attack the intestinal wall.
SYN-004 (ribaxamase) is a beta-lactamase that was designed to be orally administered with intravenous beta-lactam antibiotics and remain localized in the intestine to degrade antibiotics including penicillins and cephalosporins excreted into the intestine. “SYN-004 is designed to prevent disruption of the gut microbiome and thus protect from opportunistic gastrointestinal pathogens like C. difficile
,” explained Dr. Kokai-Kun.