Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, has initiated a phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI).

C. difficile is the leading type of hospital acquired infection and is frequently associated with intravenous (IV) antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.

"We are excited to start our phase 2a trial of SYN-004 on schedule. Synthetic Biologics believes SYN-004 holds the potential to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We anticipate reporting topline results from this phase 2a clinical trial during the second quarter of 2015, and initiating the phase 2b clinical trial in the second half of this year."

The US Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an "urgent public health threat," and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infectionsi and 30,000 C. difficile-related deathsii in the United States each year. During 2012, approximately 14 million US patients received approximately 118 million doses of IV beta-lactam antibioticsiii that could be inactivated in the GI tract by SYN-004.

The phase 2a randomized, multi-center, open-label study is expected to evaluate the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consists of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of one of two doses of oral SYN-004 and IV ceftriaxone. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants will be enrolled at up to four trial sites located in the United States and Canada.