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Synthetic Biologics to Initiate Clinical Trials of SYN-004 in 4Q 2014 to Prevent Potentially Deadly C. difficile Infections
Date:9/2/2014

odel over a 28-day dosing period, showing no evidence of toxicity to date at high, repeated doses exceeding those anticipated to be used during human clinical development. These data support Synthetic Biologics efforts to move into clinical development.

About C. difficile Infections

C. difficile is classified by the CDC as an "urgent public health threat," given its high prevalence and resistance to many drugs used to treat other infections. It affects 1.1 million Americans and causes 30,000 deaths each year,1,2 adding an estimated four to seven hospitalization days per patient3 and $8.2 billion in overall annual hospital costs.4 C. difficile infections are strongly associated with the use of IV antibiotics, which are administered to more than 24 million Americans annually to prevent or treat infections.5 These powerful antibiotics can create a harmful imbalance in the gastrointestinal tract by wiping out helpful, "good" bacteria, and allowing C. difficile to grow out-of-control, leading to severe diarrhea, damaging the colon, and in some cases, death.6

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an
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SOURCE Synthetic Biologics, Inc.
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