SAVIENT COMPLETES ENROLLMENT IN TRIAL OF GOUT TREATMENT

Savient Pharmaceuticals announced it has reached its Phase III enrollment target of 200 patients in its two placebo-controlled six-month clinical trials. The trials will assess the safety and efficacy of Puricase in patients with treatment-failure gout, under the auspices of a special protocol assessment from the FDA. The company expects to complete the in-life portion of the study during the fourth quarter and to release top-line results by the end of the year.

Puricase, a pegylated recombinant porcine urate oxidase, is being developed to control hyperuricemia and the illness' clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. 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.

"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," Zeb Horowitz, senior vice president and chief medical officer, said. "Patients and physicians continue to demonstrate satisfaction and confidence in the treatment, as evidenced by their participation in our open-label extension protocol in which patients can choose to receive Puricase or go on observation only after completion of their Phase III participation."

The company said it intends to allow patients currently in the screening process at the clinical sites to complete the screening and enroll in the Phase III clinical trials if they qualify, going somewhat beyond the 200 patient target of randomization.