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Synthetic Biologics to Acquire Clinical-Stage C. difficile Infectious Disease Program
Date:11/12/2012

mic 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.

CDI is a widespread and often drug resistant infectious disease, resulting in more than 337,000 hospitalizations and 30,000 deaths in the U.S. during 2009.[3] CDI has surpassed methicillin-resistant staphylococcus aureus (MRSA) as the most frequent infection acquired in the hospital. It has recently been reported by The Centers for Disease Control and Prevention that the current number of CDI cases may be as high as 500,000 annually in the U.S. Controlling the spread of CDI has proven challenging, as the C. diff spores are easily transferred to patients via the hands of healthcare personnel. There is currently no vaccine or approved product for the prevention of C. diff infection.

Synthetic Biologics' Product Candidate: SYN-004

The acquisition includes the clinical-stage and related beta-lactamase assets, P1A, P2A and P3A (now known as SYN-004). Phase I studies of P1A, the first compound in the series, showed acceptable safety and tolerability. In addition, two Phase II clinical studies demonstrated its ability to preserve GI microflora in hospitalized patients treated with intravenous ampicillin or the combination of piperacillin and tazobactam.

SYN-004 has a broader spectrum of activity against beta-lactam antibiotics, including both penicillins and most cephalosporins. Due to the structural similarities between P1A and SYN-004, and based on previous discussions with the FDA, it is anticipated that the preclinical and manufacturing data collected on P1A may be used in support of an IND for Synthetic Biologics' new product candidate, SYN-004, for the prevent
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SOURCE Synthetic Biologics, Inc.
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