Data from a phase 2 clinical trial show promising results for a new drug designed to prevent Clostridioides difficile infections.
In an article in The Lancet Infectious Diseases,researchers from Synthetic Biologics of Rockville, Maryland, report that the oral beta-lactamase enzyme ribaxamase, when given to patients with lower respiratory tract infections in conjunction with intravenous ceftriaxone, reduced the incidence of C difficile by 2.4 percentage points compared with placebo—a 71% relative risk reduction.
The authors of the study, which was funded, designed, and conducted by Synthetic Biologics (developer of ribaxamase), say the findings support continued clinical development of the drug.
Ribaxamase is designed to reduce C difficile risk by limiting the collateral damage caused by broad-spectrum beta-lactam antibiotics. Once in the gut, these antibiotics disrupt the natural balance of the gut microbiome and pave the way for opportunistic C difficile bacteria to spread. Ribaxamase works by degrading excess intravenous beta-lactam antibiotics that are excreted into the upper gastrointestinal tract, without interfering with the efficacy of the drugs.
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