Synthetic Biologics, an Ann Arbor, Mich.-based developer of synthetic biologics and innovative medicines for serious infections and diseases, has closed the previously announced deal with Prev AbR and acquired a series of beta-lactamase compounds (P1A, P2A and P3A) and related assets targeting the prevention of Clostridium difficile (C. diff) infection.
Utilizing the newly acquired biologic compounds, Synthetic Biologics intends to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with certain beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic and preserve the balance of the patient's gastrointestinal microflora, thus preventing opportunistic C. diff infection (CDI). Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins.
"Our company's primary focus is on the development of biologics to prevent and treat multidrug-resistant infectious diseases, and we are pleased to add the C. diff program to our pipeline. We believe we are at the forefront of developing a prophylactic to prevent the devastating effects of C. diff infection, for which there is currently no vaccine or other approved preventive therapy," said Jeffrey Riley, CEO of Synthetic Biologics. "With regulatory discussions previously initiated by Prev, we intend to continue to work with the FDA to design a regulatory pathway for a new product candidate and to advance to clinical trials as soon as possible."
C. diff is the leading cause of hospital acquired infections in which the toxins produced by the bacteria result in C. diff-associated diarrhea (CDAD), and in the most serious cases, erosion of the GI tract that can lead to death. In 2009, aggregate costs associated with CDI-related stays in the hospital were $8.2 billion in the U.S.