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Synthetic Biologics’ Ribaxamase Setback Shows Difficulty Of C. Difficile Development

 
• By Emily Hayes

Company believes there is a path forward for developing ribaxamase in Phase III, based on discussions with the FDA, but deaths in Phase II meant loss of breakthrough designation.

Business decline

Although Synthetic Biologics Inc.’ C. difficile microbiome therapy SYN-004 (ribaxamase) lost its breakthrough designation from the US FDA, looking ahead the company is focusing on the security of having a Phase III design approved by the agency. The latest setback is a sign of the challenges of the development space, which is marked by a number of trial failures.

C. difficile is a spore-forming pathogen that typically causes symptoms in individuals with altered gut microbial flora, releasing toxins. Diarrhea, pseudomembranous colitis, toxic megacolon and intestinal perforation are among the...

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