Synthetic Biologics, Inc., a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced that the United States Adopted Names Council (USAN) of the American Medical Association has approved the use of "ribaxamase" (Rye-bak'-sa-mase) for Synthetic Biologics' SYN-004. Ribaxamase is the company's phase 2 development candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.
Synthetic Biologics recently reported positive results from two phase 2a clinical trials demonstrating a correlation of the 150 mg dose of ribaxamase with the degradation of residual IV ceftriaxone alone, and in the presence of the proton pump inhibitor (PPI), esomeprazole, to levels that were near or below detectable in the intestinal chyme of healthy participants with functioning ileostomies. A phase 2b proof-of-concept, randomized, placebo-controlled clinical trial is currently underway to evaluate the ability of ribaxamase to prevent CDI and AAD in patients hospitalized with a lower respiratory tract infection and receiving IV ceftriaxone. An interim analysis of blinded data performed by an independent data monitoring committee is expected in summer of 2016.
"The approval of the generic name ribaxamase for SYN-004 by USAN is a defining milestone for Synthetic Biologics. Ribaxamase represents a newly created and innovative first-in-class drug designed to protect the naturally occurring gut microbiome from the unintended consequences of antibiotic use," said Jeffrey Riley, president and chief executive officer. "By degrading certain IV beta-lactam antibiotics before they reach the gastrointestinal (GI) tract, ribaxamase may not only prevent the onset of CDI and AAD, but has the potential to be an instrumental tool for preventing the emergence of antibiotic resistance in organisms which comprise the gut microbiome. We are excited for the continued clinical development of ribaxamase and look forward to sharing our progress including announcing results from our ongoing global phase 2b proof-of-concept clinical trial."
Synthetic Biologics also announced that an abstract has been accepted for oral presentation at ANAEROBE 2016 taking place from July 11-14 at the Sheraton Downtown Nashville Hotel in Nashville, TN. The presentation is expected to take place during Session 10: Bacterial Replacement Therapy and is scheduled for the afternoon on July 13, 2016.
Ribaxamase is a first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by commonly used IV beta-lactam antibiotics. Ribaxamase has demonstrated in clinical trials that it is not systemically absorbed, does not interfere with the efficacy of IV beta-lactam antibiotics and, by protecting the patient's native gut microbiome, may prevent the overgrowth and associated infection with Clostridium difficile as well as antibiotic-associated diarrhea. Ribaxamase has the potential to protect patients from CDI and AAD which could result in shortened hospital stays, diminished morbidity and mortality and a reduction of antibiotic resistance and costs associated with the inadvertent consequences of IV beta-lactam antibiotic use.