Synthetic Biologics to acquire clinical-stage C. diff infectious disease program

USA-based Synthetic Biologics (NYSE: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, says it has entered into an agreement with Prev AbR to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics.

Financial terms of the deal were not revealed, but the assets include a pre-Investigational New Drug package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending US and international patents intended to support an IND and Biologic License Application with the US Food and Drug Administration.

In 2009, aggregate costs associated with CDI-related stays in the hospital were $8.2 billion in the USA. CDI is a global HAI in which the toxins produced by C. diff bacteria result in diarrhea (C. diff-associated diarrhea [CDAD]), and in the most serious cases, pseudomembranous colitis (erosion of the GI tract) that can lead to death. A major, unintended risk in the use of systemic antibiotics is the development of CDI, which may alter the balance of the GI microflora that normally protect the GI tract from C. diff overgrowth and infection. Other risk factors for CDI include hospitalization, prolonged length of stay, underlying illness, immune-compromising conditions including the administration of chemotherapy, and advanced age.