Synthetic Biologics' C. difficile mid-stage study meets main goal

Last Updated: 2017-01-05

By Reuters Staff

(Reuters) - Synthetic Biologics Inc said its experimental treatment designed to reduce antibiotic-resistant infections - notably life-threatening C. difficile - outperformed a placebo in a clinical trial.

The company's oral enzyme, ribaxamase, met the main goal of significantly reducing Clostridium difficile infection, the most common cause of hospital-associated infectious diarrhea.

Ribaxamase is designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics. It was tested against a placebo in a 412-patient mid-stage study.

Seven cases of C. difficile infection were reported in the placebo group, compared to two in the ribaxamase group, a preliminary analysis showed.

"Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms," the company said in a news release.

Antibiotic-resistant infections are a grave threat to public health. A Reuters investigation has found that infection-related deaths are going uncounted, hindering the ability of the United States to fight the scourge.