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Oral enzyme designed to prevent C. difficile receives FDA breakthrough therapy designation

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Synthetic Biologics announced today that the FDA has granted a breakthrough therapy designation for SYN-004, the company’s first-in-class oral enzyme designed to prevent Clostridium difficile infection by protecting the gut microbiome from certain IV beta-lactam antibiotics.

The designation is based on data from a phase 2b trial that showed SYN-004, or ribaxamase, met its primary endpoint by significantly reducing the incidence of C. difficile infection (CDI).

According to a presentation at Digestive Disease Week, researchers randomly assigned 412 hospitalized patients at risk for CDI to receive 150 mg ribaxamase or placebo during their treatment with antibiotics and for 72 hours afterward. They analyzed 652 fecal samples from 229 patients using 16 rRNA sequencing at several pre-specified time points, and monitored all patients for 6 weeks.

Results showed that ribaxamase resulted in a 71.4% relative risk reduction in CDI (P = .0454) compared with placebo. In addition, ribaxamase also resulted in a 43.9% relative risk reduction in new colonization by enterococci that were resistant to vancomycin (P = .0002) vs. placebo. According to the company, adverse events reported during this trial were comparable between the two groups.

If approved, ribaxamase would be the first available drug of its kind for CDI prevention.

“We are delighted by the FDA’s recognition of ribaxamase’s potential to prevent CDI, and the dire need to fill the current void of an approved intervention,” Jeffrey Riley, president and CEO of Synthetic Biologics, said in a press release. “Following this announcement, we have been asked and anticipate requesting a Type-B multidisciplinary meeting with the agency for a comprehensive discussion on the overarching, high-level drug development plan and pathway to licensure for ribaxamase. We look forward to working closely with the FDA throughout the development and review process, and remain dedicated to bringing this potentially paradigm-shifting approach to antibiotic therapy in patients in critical need.”

Reference:

Kokai-Kun JF, et al. Abstract #874j. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosure: Riley is president and CEO of Synthetic Biologics.