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Synthetic Biologics Acquires C. diff Program



Published November 12, 2012
Related Searches: Manufacturing Clinical Trial Phase II Phase I
Synthetic Biologics has entered into an agreement with Prev AbR to acquire its clinical-stage and related beta-lactamase assets for the prevention of Clostridium difficile (C. diff) infection, the leading cause of hospital acquired infections (HAI), which may occur secondary to treatment with antibiotics. The assets include a pre-IND package, Phase I and II data, manufacturing process data, and all patents to support an IND and BLA with the FDA.
 
Synthetic Biologics plans to develop and commercialize an oral beta-lactamase enzyme product candidate, SYN-004, which is expected to preserve a patient’s gastrointestinal (GI) microflora, thus preventing opportunistic C. diff infection (CDI).
 
“We are pleased to add the C. diff program to our infectious disease pipeline that also includes an acinetobacter infection program. The need for an alternative mechanism of action to prevent the devastating effects of C. diff infection is critical. It is important to both improve patient care and to combat the burden of rising medical costs associated with HAI such as C. diff,” said Jeffrey Riley, chief executive officer of Synthetic Biologics. “With regulatory discussions already initiated, we are designing a regulatory pathway for our new product, SYN-004, that is intended to lead to a Phase II clinical trial as soon as possible. We look forward to reporting progress from our C. diff program when milestones are achieved.”


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