Actelion Ltd. (ALIOF) recently announced that it will initiate a phase III development program with its clostridium difficile-associated diarrhea (:CDAD) candidate, cadazolid.
The multi-center, randomized, double-blind studies will evaluate the safety and efficacy of cadazolid (250 mg, administered orally, twice daily) as compared to ViroPharma’s (VPHM) Vancocin (125 mg, administered orally, four times daily) in CDAD patients for 10 days.
This program comprises two similar studies which will evaluate whether the clinical response of cadazolid is non-inferior to Vancocin in CDAD patients and whether administration of cadazolid is superior to Vancocin in sustained clinical response. Enrolment of 1250 patients globally for the program is expected to start at the end of 2013.
The decision to advance the candidate into late-stage development was based on an exploratory phase II dose-finding study. Cadazolid was studied in a phase II multi-center, double-blind, randomized, active reference, parallel group, therapeutic exploratory study. Three doses of cadazolid (administered orally, twice daily) were evaluated for efficacy, safety and tolerability for 10 days with Vancocin as an active reference (125 mg administered orally, four times daily).
Results showed that the effect of all doses of cadazolid were either numerically similar or better than Vancocin on primary endpoints, which included CDAD cure rates as well as sustained cure rates.
Earlier this month, Actelion was in the news when it presented encouraging efficacy data on its pulmonary arterial hypertension (:PAH) candidate, Opsumit at the European Society of Cardiology from a pivotal phase III study, SERAPHIN.