Synthetic Biologics wins research contract from US CDC

The award will support research conducted during the Company's ongoing randomized, placebo-controlled Phase 2b proof-of-concept clinical study of SYN-004 (ribaxamase), designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

Clifford McDonald, Associate Director of Science for CDC's Division of Healthcare Quality Promotion, said: "Antibiotics are life-saving medicines, but they also can disrupt a person's microbiome and increase the risk for drug-resistant infections.

"To protect people, their microbiomes, and the effectiveness of antibiotics, this project is an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance."

The contract, awarded through the CDC's Advanced and Innovative Solutions to Improve Public Health Broad Agency Announcement (BAA) 2016-N-17812, will support CDC's efforts to assess how selective pressure from IV antibiotics may lead to the emergence of antibiotic resistance in the gut microbiome.

The funding will also support research to evaluate ribaxamase's ability to reduce selective pressure associated with the emergence of antibiotic-resistant organisms in the gut microbiomes of patients enrolled in the Company's ongoing Phase 2b clinical trial.

The Company will examine DNA isolated from longitudinal samples obtained during the clinical trial and look for changes to the patient's gut resistome, specifically examining for alterations in the presence and/or abundance of antibiotic resistance genes.

Jeffrey Riley, President and Chief Executive Officer, said: "Synthetic Biologics is proud to have the support of the U.S. Government in its efforts to study the role of antibiotics in mediating resistance in the gut microbiome.

"Ribaxamase's strategy of degrading certain IV beta-lactam antibiotics before they are excreted into the GI tract has the potential to protect the gut microbiome from disruption by these antibiotics without inhibiting their ability to fight primary infections as well as mitigate conditions conducive to antibiotic-resistance development.

"We look forward to our collaboration with CDC and to furthering their initiative to assess and address rising global concerns for the proliferation of antibiotic resistance."

About the Centers for Disease Control and Prevention (CDC)

The Centers for Disease Control and Prevention (CDC) serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States.

As the nation's health protection agency, CDC saves lives and protects people from health threats. To accomplish its mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats, and responds when these arise.

About SYN-004 (ribaxamase) and the Ongoing Phase 2b Study

SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and the emergence of antibiotic-resistant organisms.

The ongoing Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of C. difficile infection (CDI), C. difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving intravenous (IV) ceftriaxone.

The Company anticipates announcing top-results from this study during the first quarter of 2017.