NORTHBROOK, Ill., May 14, 2014 /PRNewswire/ -- Astellas reported today that the efficacy and safety data of the isavuconazole invasive aspergillosis study (SECURE) were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain.
Previously announced topline data showed that the randomized, double-blind SECURE study met the primary objective of demonstrating non-inferiority of isavuconazole versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi.
Baseline characteristics of the severely ill patient population enrolled in this trial were balanced between treatment groups and were reflective of patients at risk for invasive fungal disease (mean age of 51 years, 84% hematologic malignancies, 66% neutropenic and 20% allogeneic haematopoietic stem-cell transplantation).
The primary endpoint of all-cause mortality through day 42 in the intent-to-treat population (ITT, N=516) was 18.6% in the isavuconazole (ISA) treatment group and 20.2% in the voriconazole (VRC) group. The upper limit of the 95% confidence interval of the adjusted treatment group difference was 5.7% which is below the pre-specified 10% non-inferiority margin. All-cause mortality through day 42 in patients with proven/probable invasive fungal disease (modified intent-to-treat, mITT population) was 19.6% (ISA) and 23.3% (VRC).
Overall response (a composite of clinical, mycological and radiological responses) at end-of-therapy in the mITT population as assessed by the independent data review committee was 35.0% for isavuconazole versus 36.4% for the comparator voriconazole.
Treatment emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary (8.9% vs. 16.2%), skin (33.5% vs. 42.5%) and eye disorders (15.2% vs. 26.6%). In addition, isavuconazole (42.4%) showed statistically fewer study drug-related adverse events relative to voriconazole (59.8%). In both treatment groups, the most common treatment emergent AEs for isavuconazole and voriconazole respectively were nausea (27.6% vs. 30.1%), vomiting (24.9% vs 28.2%), pyrexia (fever) (22.2% vs 30.1%) and diarrhea (23.7% vs 23.2%).
"The SECURE study results demonstrate that isavuconazole is active against both Aspergillus spp. and emerging molds and could represent a step forward for patients suffering from these life-threatening infections," said Bernhardt Zeiher, M.D., executive vice president, global development.
Isavuconazole posters and presentations at ECCMID 2014
- A phase 3 randomised, double-blind trial evaluating isavuconazole vs. voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus spp. or other filamentous fungi (SECURE) J. Maertens, T. Patterson, G. Rahav, D. Kontoyiannis, K. Marr, R. Maher, M. Lee, B. Zeiher, A. Ullmann; Oral presentation O230a
- Pharmacodynamics of the new azole isavuconazole (ISA) in an Aspergillus fumigatus mouse infection model S. Seyedmousavi, J. F. Meis, R. J. M. Brüggemann, W. J. G. Melchers, P. E. Verweij, J. W. Mouton; Poster P1698
- In vivo efficacy of isavuconazole and amphotericin B in a non-neutropenic murine model of disseminated Absidia corymbifera P. Warn, A. Sharp; Poster P0106
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections. It is currently in phase 3 of clinical development.
Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as activity in in-vitro studies and in animal models against emerging and often fatal molds including those that cause mucormycosis. In the U.S., isavuconazole was granted FDA fast-track status and received QIDP and orphan drug designation for invasive aspergillosis and mucormycosis (zygomycosis). Isavuconazole is being co-developed with Basilea Pharmaceutica Ltd.
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas, please visit www.astellas.us or follow us on Twitter at @AstellasUS.
Logo - http://photos.prnewswire.com/prnh/20140416/84970