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.
The Impact program (International Multi-center Program Assessing Cadazolid Treatment in patients suffering from Clostridium difficile-associated diarrhea) comprised two identical Phase III studies that were designed as multi-center, randomized, double-blind studies to compare the efficacy and safety of cadazolid versus vancomycin in patients with Clostridium difficile-associated diarrhea (CDAD). Primary endpoint of the studies was the clinical cure rate at end of treatment (+ 2 days). The clinical cure rate was defined as the resolution of diarrhea (less than or equal to 3 unformed bowel movements per days for at least 2 consecutive days) and no further need for CDAD therapy on study treatment and maintained for 2 days after the end of study treatment.
Actelion, phase iii, impact program, cadazolid, cdad
