However, the company intends to allow patients currently in the screening process to enroll in the phase III clinical trials if they qualify, going beyond the 200 patient target.
“Allowing them to complete the screening process will translate into an extension of patient randomization for about two additional weeks, but it should not jeopardize subsequent key milestone dates,” said Zeb Horowitz.
The phase III study design designates the normalization of uric acid during months three and six of the six-month trials as the primary endpoint. Secondary efficacy endpoints that define clinical outcomes such as the reduction in the burden of gout tophi, the occurrence of gout flares, and the reduction in the count of tender and swollen joints will be analyzed in a data set pooled from the two replicate studies numbers.
“Up to this point, the tolerability of intravenous dosing has been good, with a low rate of infusion reactions across all placebo and Puricase infusions. Even more importantly, physicians appear to be highly successful in treating through infusion reactions when they do occur, just as in clinical practice with other infused biologicals,” stated Zeb Horowitz, senior vice president of Savient.
The company expects results from the phase III trials will be released by year-end. Savient remains on target for a biologics license application filing in early 2008.