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, announced today positive results from its final preclinical toxicology study of SYN-004. Per U.S. Food and Drug Administration (FDA) guidance, this bridging study was required to move the Company's lead anti-infective, second-generation product candidate designed to prevent the devastating effects of Clostridium difficile (C. difficile), toward the clinic.
The Company is in the final stages of preparing its SYN-004 IND application for submission to the FDA, with the expectation of initiating Phase Ia and Ib clinical trials in the fourth quarter of 2014, and a Phase II efficacy study in the first half of 2015.
"As the need for a preventative for C. difficile infections continues to increase globally, moving our SYN-004 program toward the clinic is more important than ever," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "SYN-004 is unique from other C. difficile preventative approaches in development, as it is designed to protect and maintain the microbiome, and prevent the proliferation and devastating effects of C. difficile infections. Research continues to demonstrate that protection of the microbiome also plays an increasingly important role in the prevention of a variety of GI, metabolic and CNS disorders."
Mr. Riley concluded, "In addition, SYN-004 is provided only when necessary – as a patient receives IV antibiotics and is at greatest risk of developing C. difficile. Synthetic Biologics' point-of-care preventative approach contrasts significantly with approaches that require mass vaccination."
In the preclinical toxicology study, oral SYN-004 was safe and well tolerated in a canine model 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.
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