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Synthetic Biologics on Track to Initiate Clinical Program for SYN-004 to Protect Against C. difficile
Date:8/5/2014

ROCKVILLE, Md., Aug. 5, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, today announced that, with a new multi-service agreement in place, the Company is on track to initiate Phase Ia and Ib clinical trials of SYN-004 for the prevention of Clostridium difficile (C. difficile) during the fourth quarter of 2014. The Company has entered into an agreement with Evonik for oral formulation development, analytical services, and clinical drug manufacturing in accordance to GMP guidelines, of the Company's proprietary oral beta-lactamase enzyme, SYN-004, for use in the planned clinical trials. Evonik plans to formulate and encapsulate enterically coated SYN-004 for oral delivery using material generated by Synthetic Biologics' API manufacturer FUJIFILM Diosynth Biotechnologies UK Limited.

SYN-004 is designed as the first and only prophylactic treatment intended to prevent the development of C. difficile infections, by binding with and neutralizing certain intravenous (IV) beta-lactam antibiotics in the gut. SYN-004 is intended to block the effects of antibiotics within the gastrointestinal tract, maintaining the natural balance of bacterial flora (the gut microbiome), potentially preventing the 1.1 million C. difficile infections in the U.S. each year1.

"SYN-004 has the potential to have a significant impact on mitigating the effects of C. difficile, a major public health issue, and we are thrilled to be advancing rapidly toward the clinic with our novel and differentiated approach," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "While we await the topline results of the ongoing toxicology study, we are pleased to have begun working with our strategic partner Evonik, to optimize
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SOURCE Synthetic Biologics, Inc.
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