Positive Results for Basilea's Novel Broad Spectrum Antifungal Agent
Basilea Pharmaceutica Ltd. announced positive results from its phase II clinical trial evaluating BAL8557, Basilea's broad-spectrum antifungal. The trial was conducted in patients with esophageal candidiasis, a common infection in immunocompromised patients.
The phase II study compared three dosing regimens of BAL8557 to fluconazole in the treatment of esophageal candidiasis, to demonstrate antifungal efficacy in patients. All three BAL8557 dosing regimens were highly effective for the stringent primary endpoint of endoscopically confirmed complete clinical cure. Excellent activity was also confirmed in secondary endpoints, including microbiological cure, therapeutic responses and follow-up assessments at two and four weeks. In the trial, BAL8557 was safe and well tolerated with an adverse event profile comparable to fluconazole. Planned phase III trials will target severe invasive yeast (candida) and mold infections (including aspergillus and zygomycetes).
BAL8557's extended antifungal spectrum covers most yeasts and molds causing serious infections in immunocompromised patients including fluconazole resistant candida strains and zygomycetes. BAL8557 is designed as a water-soluble prodrug that is suitable for both oral and intravenous administration. Furthermore, the study results confirm the possibility to develop convenient once-daily and once-weekly dosing regimens.
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