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Synthetic Biologics Initiates Manufacturing Process for C. difficile Infectious Disease Program
Date:7/18/2013

ention of C. difficile infections (CDI), the leading cause of hospital acquired infections (HAI), that generally occur secondary to treatment with intravenous antibiotics. The acquired assets include a pre-Investigational New Drug (IND) package for SYN-004, a 2nd generation oral enzyme candidate (formerly known as Ipsat Therapeutics P3A); Phase I and Phase II clinical data for P1A (a 1st generation oral enzyme candidate); manufacturing processes and data; and, a portfolio of issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the U.S. Food and Drug Administration.

Utilizing this portfolio of assets, the Company intends to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with certain intravenous beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic that is excreted in the gastrointestinal (GI) tract, thus preserving the natural balance of the patient's microflora, and preventing opportunistic infections including CDI. Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin classes of antibiotics. In 2012, 15 million Americans were administered beta-lactam antibiotics.*

Compared to the 1st generation oral enzyme candidate, P1A, the Company believes that SYN-004 will be able to degrade a broader spectrum of beta-lactam antibiotics, including both penicillins and cephalosporins. Due to the structural similarities between P1A and SYN-004 for the prevention of CDI, along with previous discussions with the FDA, it is anticipated that certain preclinical data collected on P1A may be used in support of an IND for the Company's new product candidate, SYN-004.

About Clostridium difficile (C. difficile) Infections

According to the Agency for Healthcare Research and Quality, aggregate costs
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SOURCE Synthetic Biologics, Inc.
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