Pfizer To Take Zinplava Rival Into Phase III For C Diff
Pfizer will start a Phase III trial for its Clostridium difficile vaccine by the middle of the year, taking aim at the chinks in the armour of Merck & Co’s recently approved Zinplava, but it still trails its rival from Sanofi.
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Pfizer’s Clostridioides difficile vaccine candidate missed a Phase III primary endpoint but the company may seek a path forward based on secondary endpoints even after past failures in the field.
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.
Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.