Actelion's novel antibiotic cadazolid to move into Phase III clinical development in patients suffering from Clostridium difficile associated diarrhea
Actelion 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. Cure rate was defined as the resolution of diarrhea and no further need for CDAD therapy at test-of-cure 24 to 72 hours after the last dose of treatment, while sustained cure rate was defined as cured with no recurrence of diarrhea up to 4 weeks post-treatment.
Recurrence rates were numerically lower for all doses of cadazolid as compared to vancomycin. Recurrence rate was defined as a new episode of diarrhea and a positive Clostridium difficile toxin test.
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