11 May 2017 - FDA action marks first breakthrough therapy designation for clinical program designed to prevent primary clostridium difficile infection.
Synthetic Biologics today announced that the U.S. FDA has granted a breakthrough therapy designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection.
SYN-004 (ribaxamase) is the company's first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous beta-lactam antibiotics.