Cadazolid (Actelion) moves into Phase III for Clostridium difficile

Actelion has announced that it has decided to move forward with Phase III clinical development of cadazolid in patients suffering from Clostridium difficile associated diarrhea (CDAD). The decision is based on the results of a therapeutic exploratory Phase II dose-finding study randomizing 84 patients. The study evaluated the efficacy, safety and tolerability of 3 doses of cadazolid (administered orally, twice-daily) versus vancomycin, as an active reference, (125 mg administered orally, four times daily) for 10 days.

The study, with a limited sample size, was not designed to compare statistically cadazolid versus vancomycin. The results of this Phase II study indicate that the effect of all doses of cadazolid are numerically similar to, or better than vancomycin on key endpoints including CDAD cure rates as well as sustained cure rates.