Astellas antifungal misses in Phase III

Astellas Pharma Inc. (Toyko:4503) released top-line results from the Phase III ACTIVE trial of Cresemba isavuconazonium to treat Candida infection, saying that the broad-spectrum water-soluble azole antifungal missed its primary endpoint.

Cresemba failed to show non-inferiority to Cancidas caspofungin in an intent-to-treat analysis of 400 adult patients with candidemia and other invasive Candida infections (a total of 440 patients were enrolled). There was a 60.3% treatment response after 10 days in the Cresemba group vs. 71.1% in the caspofungin group (-10.8%; 95% CI: -19.9%, -1.8%). The lower bound of the confidence interval exceeded the pre-specified non-inferiority margin of -15%. ...