Synthetic Biologics’ Ribaxamase Setback Shows Difficulty Of C. Difficile Development
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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
The Swiss specialty drug company gains a Phase III microbiome product for the prevention of recurrent Clostridium difficile infection and a broader platform for Microbiota Restoration Therapy.