Cadazolid meets primary endpoint in IMPACT-1 study and but not in IMPACT-2 study versus vancomycin in the treatment of Clostridium difficile-associated diarrhea.- Actelion/J&J

Actelion Ltd has provided an update on the Phase III program IMPACT to investigate the efficacy and safety of Actelion's novel anti-infective cadazolid versus vancomycin in the treatment of Clostridium difficile-associated diarrhea (CDAD).

In the pivotal program, IMPACT 1 met its primary endpoint, while the second study IMPACT 2 did not meet the primary endpoint. Cadazolid demonstrated an acceptable tolerability and safety profile in the IMPACT program. IMPACT 1 and 2 compared 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). A total of 1263 patients worldwide participated in the IMPACT program, which assessed as primary endpoint whether the clinical response after administration of cadazolid is non-inferior to vancomycin in patients with CDAD.

The company will now work diligently to complete the analyses of the full study results and detailed results will be made available through scientific disclosure at upcoming congresses and in peer-reviewed publications.