Microbiome Therapy for C. diff Clears Phase 2 Clinical Trial

Ribaxamase significantly reduced Clostridium difficile infection in a mid-stage clinical trial involving more than 400 patients.

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Clostridium difficile colonies on blood agarCDC, HOLDEMANClostridium difficile (C. diff ) is one of the most common hospital-acquired infections, in part because of its ability to opportunistically colonize the GI tract after antibiotics have disrupted the natural balance of the gut microbiome. But results from a Phase 2 clinical trial announced yesterday (January 5) suggest that Synthetic Biologics’s SYN-004 (ribaxamase) may help degrade certain antibiotics within the GI tract, maintaining the status quo in the gut microbiome and preventing C. diff infection.

The randomized, double-blind trial involved 412 patients, half of whom received 150 mg of ribaxamase and half of whom received a placebo. By the end of the trial, there were seven cases of C. diff infection in the placebo group but only two in the test group, representing a 71.4 percent relative risk reduction.

The successful trial represents “a significant milestone in the clinical development of ribaxamase,” Jeffrey Riley, president and CEO of Synthetic Biologics, said in a press release. “These findings also help further our goals to bring the first ever microbiome-focused therapeutic to patients and to help illuminate the potential of this drug class to address serious diseases and public health concerns.”

Ribaxamase, an oral enzyme, targets beta-lactam antibiotics, which can save lives ...

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