Basilea Pharmaceutica, BARDA Collaboration Progresses for Isavuconazonium Sulfate in Invasive Aspergillosis
New Data Presented at ECCMID and Additional Trial Planned
Basilea Pharmaceutica AG announced the full results from a phase 3 study evaluating isavuconazonium sulfate for invasive aspergillosis (IA) at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
The GALACTIC trial (NCT03091358) did not meet its primary endpoint of non-inferiority to voriconazole based on the modified intent-to-treat population (MITT), which included all randomized patients who received at least one dose of study drug and had baseline and post-baseline assessments. However, a treatment benefit was seen with isavuconazonium in the subgroup with less severe disease.
The safety profiles of isavuconazonium and voriconazole were generally similar in the study. In the MITT population, serious adverse events were reported in 26.9% of isavuconazonium-treated patients and 26.4% of voriconazole-treated patients, and treatment-emergent adverse events leading to discontinuation occurred in 6.5% and 7.3%, respectively.
Additional Trial Planned
The collaboration between Basilea and the Biomedical Advanced Research and Development Authority (BARDA) will expand to include a new phase 3 clinical trial. The new trial will assess the use of isavuconazonium as prophylaxis for invasive fungal disease in immunocompromised hematology and oncology patients.
"We are grateful for the work of the investigators and patients who participated in the GALACTIC trial," said Ronald Scott, CEO of Basilea. "We look forward to working with BARDA to explore the potential of isavuconazonium in this important at-risk population."
About Isavuconazonium Sulfate
Isavuconazonium sulfate is indicated for the treatment of invasive aspergillosis and mucormycosis in patients 18 years of age and older.
Isavuconazonium was discovered by Basilea in collaboration with Astellas Pharma Inc. and is marketed by Basilea in Europe, Canada and Israel and by Astellas in the United States, Japan, and other countries.
About BARDA
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, invests in the development of innovative medical countermeasures against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases.
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