Actelion is initiating Phase III clinical development of cadazolid in patients suffering from Clostridium difficile associated diarrhea

12-Sep-2013 - Switzerland

Actelion announced that it will initiate a Phase III clinical development program to assess the efficacy and safety of cadazolid in patients with Clostridium difficile-associated diarrhea (CDAD).

The Phase III program consists of two identical multi-center, randomized, double-blind studies comparing the efficacy and safety of cadazolid, (250 mg administered orally twice daily for 10 days) versus vancomycin, (125 mg administered orally four times daily for 10 days) in subjects with Clostridium difficile-associated diarrhea (CDAD).

The program is designed to determine whether the clinical response after administration of cadazolid is non-inferior to vancomycin in patients with CDAD, and whether administration of cadazolid is superior to vancomycin in the sustained clinical response.

The program is expected to enroll more than 1'250 patients worldwide, and is planned to commence enrollment in the fourth quarter of 2013.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "The cadazolid Phase III program will address the essential clinical and commercial requirements for a novel CDAD therapy to be successful, with a focus on making a meaningful difference for patients. Evidence of a superior sustained cure compared to vancomycin, including in hypervirulent strains, would go a long way to meeting the most pressing current medical need. The promising profile of cadazolid underlines Actelion's commitment to finding new classes of antibiotics which have a reduced risk of developing resistance."

https://www.bionity.com/en/news/144911/actelion-is-initiating-phase-iii-clinical-development-of-cadazolid-in-patients-suffering-from-clostridium-difficile-associated-diarrhea.html