Vicuron Pharmaceuticals: Phase 3 Trial Results Demonstrate Superiority of Anidulafungin in Invasive Candidiasis/Candidemia
Vicuron Pharmaceuticals Inc. announced results from its Phase 3 clinical trial evaluating anidulafungin for the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection.
The study compared anidulafungin to fluconazole, and was designed to show non-inferiority. Anidulafungin was superior to fluconazole in the primary endpoint, global response at the end of intravenous therapy in the microbiological intent-to-treat population. Anidulafungin also demonstrated non-inferiority or superiority in all secondary endpoints, including responses at the two-week and six-week follow-up visits after completion of therapy. Anidulafungin was well tolerated in the study, with a side effect profile comparable to fluconazole.
The double-blind, multi-center, randomized Phase 3 trial studied a 100 mg daily dose of anidulafungin versus a 400 mg daily dose of fluconazole in 256 patients with invasive candidiasis/candidemia. Patients received daily intravenous (IV) infusions of either anidulafungin or fluconazole for 10 to 42 days. The primary endpoint was the global response at the end of IV therapy, which required a successful clinical and a successful microbiological response. Results from the study included:
Success in the global response at the end of IV therapy in the microbiological intent-to-treat population was 75.6 percent (96/127) of patients with anidulafungin and 60.2 percent (71/118) with fluconazole. These results demonstrate statistical superiority (95 percent confidence interval of the difference: 3.85, 26.99).
The secondary endpoint of successful global response at the two-week follow up visit in the microbiological intent-to-treat population was observed in 64.6 percent (82/127) of patients in the anidulafungin arm and 49.2 percent (58/118) of patients in the fluconazole arm, again demonstrating statistical superiority (95 percent confidence interval of the difference: 3.14, 27.68).
The secondary endpoint of successful global response at the six-week follow up visit in the microbiological intent-to-treat population was observed in 55.9 percent (71/127) of patients in the anidulafungin arm and 44.1 percent (52/118) of patients in the fluconazole arm demonstrating non- inferiority (95 percent confidence interval of the difference: -0.6, 24.28).
Anidulafungin demonstrated comparable tolerability to fluconazole in the study.
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