The multi-center, randomized, controlled, four-arm study evaluates two different oral daily schedules of BAL8557, versus a weekly oral dose regimen, in comparison to fluconazole over a standard 14 to 21 day evaluation period.
The study is planned to enroll approximately 160 oesophageal candidiasis patients and results are expected in the second half of 2005.
BAL8557 is a novel water-soluble azole intended for both oral and intravenous use in severe fungal infections. Phase I studies were successfully completed in the first half of 2004 and demonstrated that BAL8557 had a predictable pharmacokinetic profile and was well tolerated by both intravenous and oral routes.
“Invasive fungal infections are a major cause of morbidity and mortality in seriously immuno-compromised patients,” commented Dr Rienk Pypstra, Basilea’s chief development officer. “We believe that BAL8557 has the potential to become a leading systemic anti-fungal drug on the basis of its broad-spectrum profile and convenient dosing that would benefit patients and physicians alike.”