Fast track designation is intended to expedite the availability of treatments that address unmet medical needs for serious and life-threatening diseases.
Invasive fungal infections are a major cause of morbidity and mortality in patients with weakened immune systems. According to the company, the overall rate of invasive fungal infections in these patients is approximately 25% and mortality ranges from 50% to 100%.
The number of drugs available to treat severe infections caused by invasive fungi such as zygomyces is limited.
“We have a broad product development strategy for invasive yeast and mold infections. We also recognize that patients with such infections and impaired renal function have limited treatment options because many existing drugs can further impair kidney function,” said Dr Anthony Man, Basilea’s CEO.
In September last year Basilea reported positive phase II results on BAL8557 in the treatment of esophageal candidiasis. The safety profile of BAL8557 in those patients was observed to be similar to that of fluconazole. Pivotal phase III trials in invasive fungal infections are scheduled to start in the second half of 2006.