The FDA has granted breakthrough therapy status to ribaxamase (Synthetic Biologics) for the prevention of Clostridium difficile infection (CDI). Ribaxamase is a first-in-class oral enzyme designed to degrade certain intravenous (IV) beta-lactam antibiotics in the gastrointestinal tract and to maintain the natural balance of the gut microbiome for the prevention of CDI, pathogenic overgrowth, and the emergence of antimicrobial resistance.
The breakthrough therapy designation was based on positive data from a phase 2b proof-of-concept clinical trial that was designed to evaluate the efficacy of ribaxamase in preventing the onset of primary CDI, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance in patients hospitalized with a lower respiratory-tract infection and receiving IV ceftriaxone. The study’s primary endpoint was the reduction in CDI.
Patients treated with ribaxamase achieved a 71% relative risk reduction (P = 0.045) in CDI rates compared with those given placebo. The data also demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci among patients treated with ribaxamase compared with the placebo group (P = 0.0002).
If approved by the FDA, ribaxamase would be the first drug designed to prevent CDI by protecting the gut microbiome from antibiotic-mediated dysbiosis.
Source: Synthetic Biologics; May 11, 2017.