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C Diff. Prevention Candidate Heads Into Clinic With Ambitious Timetable

Synthetic Biologics thinks it can produce first product to prevent C. difficile infections by protecting microbiome from impact of I.V. beta lactam antibiotics; biotech plans IND in next two months and hopes to produce proof-of-concept data within roughly one year.

With success in a 28-day preclinical safety and tolerability study, Synthetic Biologics Inc. believes it is on the cusp of bringing the first drug to prevent Clostridium difficile infections into clinical development, with an ambitious timeline to move into Phase II testing during the first half of 2015.

Based in Rockville, Md., Synthetic Biologics’ SYN-004 is an oral, second-generation anti-infective based on a prior compound licensed from now-shuttered Finnish biotech Ipsat Therapies Oy. The company plans to...

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