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CDC to fund research on microbiome therapy for prevention of antibiotic side effects

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The CDC has awarded Synthetic Biologics with a contract to support research related to the company’s phase 2b proof-of-concept clinical trial of SYN-004, according to a press release.

SYN-004 (ribaxamase; Synthetic Biologics) is an oral enzyme designed to degrade certain IV beta-lactam antibiotics in the GI tract to protect the gut microbiome and prevent Clostridium difficile infection, antibiotic-associated diarrhea and the emergence of antibiotic-resistant organisms.

The ongoing randomized, placebo-controlled trial is evaluating the agent’s effectiveness for preventing these unintended effects in hospitalized patients with lower respiratory infections who are receiving IV ceftriaxone, the results of which are expected in the first quarter of next year.

Clifford McDonald



“Antibiotics are life-saving medicines, but they also can disrupt a person’s microbiome and increase the risk for drug-resistant infections,” Clifford McDonald, MD, associate director of science for CDC’s division of health care quality promotion, said in the press release. “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 was issued via the CDC’s Advanced and Innovative Solutions to Improve Public Health Broad Agency Announcement (BAA) 2016-N-17812, and will support the CDC’s assessment of how the emergence of antibiotic-resistance in the gut microbiome may be spurred by selective pressure from IV antibiotics. In addition, it will support the study of the effectiveness of ribaxamase in reducing selective pressure associated with the emergence of antibiotic-resistance organisms in trial participants’ gut microbiomes. Synthetic Biologics will evaluate alterations in patients’ gut resistomes using DNA isolated from longitudinal samples, specifically looking for changes in the presence and abundance of antibiotic resistance genes.

“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,” Jeffrey Riley, President and CEO of Synthetic Biologics, said in the press release. “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.”

Disclosures: Riley is employed by Synthetic Biologics.