Top-line Data on Astellas' Isavuconazole

Astellas Pharma, Inc. ( '>ALPMY )  announced positive top-line data from a phase III study (:SECURE) on its invasive aspergillosis candidate, isavuconazole. Isavuconazole is an azole antifungal agent, jointly developed by Basilea Pharmaceuticals AG and Astellas. The companies had entered into an agreement in Feb 2010.

The global, double-blind, randomized phase III study evaluated the safety and efficacy of once-daily isavuconazole versus Pfizer Inc.’s (PFE) Vfend (twice daily). The study achieved its primary objective of non-inferiority to Vfend for the treatment of invasive fungal disease caused by the Aspergillusspecies. The all-cause-mortality was 18.6% in the isavuconazole arm and 20.2% in the Vfend arm.

The secondary endpoint of overall success rate at the end-of-therapy in patients with proven/probable disease was almost similar between the two groups.

As per information provided by Astellas, invasive aspergillosis is found in 5-13% of bone marrow transplant patients, 5-25% of heart or lung transplant patients and 10-20% of recipients of intensive chemotherapy patients for leukemia.

Besides the SECURE study, the candidate is currently being evaluated in two other phase III studies, namely, VITAL and ACTIVE.

The open-label phase III VITAL study evaluates isavuconazole for the treatment of patients with invasive life-threatening fungal disease and the treatment of aspergillosis patients with pre-existing renal impairment. Enrolment is complete and the review of diagnosis and outcomes by the Independent Data Review Committee is in progress.

The double-blind, randomized phase III ACTIVE study evaluates the use of isavuconazole (intravenous and oral) versus Merck & Co, Inc.’s (MRK) Cancidas (intravenous) followed by Vfend (oral) for the treatment of candidemia and other invasive candida infections. The enrollment in the ACTIVE study is in progress.

The U.S. Food and Drug Administration (:FDA) has granted fast track and orphan drug designation to isavuconazole.

Currently Actavis Inc. (ACT) is also developing an antifungal agent, albaconazole. The candidate is being developed for the treatment of vulvo-vaginal candidiasis, onychomycosis and other antifungal indications.