Grant Funding Study of Gut Microbe Protection Drug

Yellow-green fluorescence of C. difficile bacteria (Centers for Disease Control and Prevention)

6 October 2016. A biotechnology company developing drugs that protect the natural microbial balance in the gastrointestinal tract is receiving funds to learn how its drugs affect antibiotic resistance. Centers for Disease Control and Prevention, or CDC, awarded Synthetic Biologics Inc. in Rockville, Maryland one of 34 awards — and the only industry recipient — in a $14 million research initiative to combat antibiotic resistance.

Synthetic Biologics produces therapies for infectious diseases that still protect the natural microbial balance in the gastrointestinal tract. One of its drugs in development is ribaxamase, code-named SYN-004, designed to prevent infections from Clostridium difficile or C. difficile bacteria. According to CDC, almost a half-million C. difficile infections occurred in the U.S. in 2011, leading to 29,000 deaths within 30 days of diagnosis.

C. difficile infections are often contracted in health care facilities, such as clinics and hospitals, causing inflammation in the colon, and symptoms including watery diarrhea, abdominal pain, nausea, loss of appetite, and fever. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of this disease.

SYN-004 is a synthetic enzyme formulated as an oral drug to degrade a common type of antibiotics, known as beta-lactam antibiotics, in the gastrointestinal tract. Beta-lactam antibiotics include widely used penicillins and cephalosporins, administered through intravenous infusions, which can pass into the gastrointestinal tract and kill helpful microbes, such as those that naturally protect against C. difficile infections. By degrading beta-lactam antibiotics, SYN-004 protects helpful microbes, thus preserving the body’s natural defenses against C. difficile.

The CDC grant funds a study by Synthetic Biologics to assess the way pressure from intravenous antibiotics encourages the emergence of antibiotic resistance in gut microbial communities. The company plans to extract DNA samples from participants enrolled in an intermediate-stage clinical trial testing SYN-004 against a placebo to prevent C. difficile infections. The trial is enrolling patients receiving ceftriaxone, a type of beta-lactam antibiotic, administered intravenously, for lower respiratory infections. The study team will look for changes in the presence and number of genes associated with antibiotic resistance in those DNA samples.

Synthetic Biologics is the only grant recipient from industry in the initiative, with the other investigators coming from universities and OpenBiome, a not-for-profit organization. OpenBiome operates a stool bank that collects fecal samples for research and transplants, a treatment option for C. difficile infections.

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