Astellas Reports Success In Phase 3 For Isavuconazole In Mucormycosis

Astellas is reporting at IDWeek in Philadelphia, PA that VITAL, a Phase 3 study of isavuconazole, was successful in the treatment of invasive mucormycosis, a rare and often fatal fungal infection. The data assessing the efficacy and safety of isavuconazole was announced in a press release. An independent data review committee evaluated clinical, mycological, and radiological criteria and found a 31.4 percent overall response rate.

Bernie Zeiher, M.D., EVP of Global Development at Astellas, said, "The VITAL study results which demonstrate that isavuconazole is active against mucormycosis, are promising, as this is a highly fatal disease in which patients are often refractory to or intolerant of treatment.”

Isavuconazole

Isavuconazole (isavuconazonium sulfate), proposed trade name of Cresemba, is a once-daily intravenous and oral broad-spectrum antifungal. Astellas has submitted a New Drug Application (NDA) for isavuconazole to the Food and Drug Administration (FDA) for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). The FDA must take action on the application by March 8, 2015. The FDA has designated isavuconazole as a Qualified Infectious Disease Product (QIDP) and given the agent Orphan Drug status. Isavuconazole is being co-developed with Basilea, who holds the full rights to isavuconazole in all markets except the U.S. and Canada, where Astellas holds the rights.

Isavuconazole Phase 3 Program

The Isavuconazole Phase 3 Program includes the SECURE, VITAL, and ACTIVE studies. Astellas is reporting on the VITAL study, a multi-center study of 37 patients with invasive mucormycosis. Investigators found that 31.4 percent of patients achieved an overall response. On day 84, 11 patients that were refractory, not yielding to treatment, remained alive. No new safety issues were revealed and common side effects included vomiting, diarrhea, and nausea.

IDWeek 

IDWeek is the annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The participants are expected to discuss the urgency of treatments for diseases and conditions, such as the Ebola virus, Middle East respiratory syndrome (MERS), the Chikungunya virus, and enterovirus D68. Sessions on influenza, HIV, and antibiotic resistance are expected to be well attended. T2 Biosystems, Cubist, and Astellas are among the industry presenters at the meeting.