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| Synthetic Biologics' SYN-004 (blue) is designed to be given alongside antibiotics (gray diamonds) that are known to cause C. diff infection.--Screenshot courtesy of a Synthetic Biologics video |
As the threat of superbugs rise amid growing resistance to antibiotics, Clostridium difficile infections are becoming more common in healthcare settings across the U.S.
To combat this serious infection, two small biotechs have unveiled positive preclinical data backing potential new therapies. Rockville, MD-based Synthetic Biologics ($SYN) and Oxford, U.K.-based Summit presented independent data on their respective anti-infectives at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, this week.
Synthetic Biologics' lead candidate, SYN-004, effectively degraded a broad spectrum of commonly used intravenous antibiotics known to cause C. difficile infections, including cephalosporins. Designed as an oral tablet, SYN-004 is intended as a preventive treatment to protect the gut microbiome from the effects of certain antibiotics commonly used in hospitals.
The company plans to apply for an Investigational New Drug application for SYN-004 as well as launch Phase I clinical trials by the end of the year and a Phase II efficacy study in the first half of 2015.
Meanwhile, in a series of preclinical in vivo and in vitro tests, Summit's oral antibiotic, SMT19969, displayed increased survival rates and prevention of recurrent disease, superior bacterial killing and reduced toxin B production compared to vancomycin, the current standard of care for the treatment of C. difficile infection.
In hamsters, SMT19969 provided 100% survival during infection. In recurrent infections, which were greatly reduced by the drug, SMT19969 provided 80% to 100% survival. Vancomycin, on the other hand, was associated with survival rates of 0% to 10% in the case of recurrent infection.
The U.S. Centers for Disease Control and Preventions classifies C. difficile as an "urgent public health threat," given its high prevalence and resistance to many drugs used to treat other infections. It affects 1.1 million Americans and causes 30,000 deaths each year.
- get the research abstracts from Summit
- read the announcement from Summit
- and see the statement from Synthetic Biologics