Savient says additional phase 2 results promising for Puricase as gout treatment

By E. Janene Geiss

Philadelphia, June 22 - Savient Pharmaceuticals, Inc. said Thursday that additional phase 2 results are promising for its phase 3 compound Puricase (PEG-uricase), which is being developed for the control of hyperurecemia in treatment-failure gout.

The phase 2 randomized, open-label, multi-center trial assessed the urate response and pharmacokinetic and safety profiles of Puricase in patients with hyperurecemia and severe gout who are unresponsive to or intolerant of conventional therapy, according to a company news release.

In the study, 41 patients were randomized to 12 weeks of treatment with intravenous Puricase at one of four dose regimens: 4 mg every two weeks; 8 mg every two weeks; 8 mg every four weeks; or 12 mg every four weeks.

Patients who received 8 mg of Puricase every two weeks had the greatest reduction in plasma urate with levels below 6 mg/dL 92% of the treatment time, officials said.

A total of 27 study patients received all intended doses. Thirty-eight patients experienced an adverse event that was possibly treatment-related, most commonly gout flare, officials said.

As expected with biological administration, there was a high rate of infusion reaction: 23 patients experienced 34 events that occurred within 24 hours of infusion; 21 of these events in 18 subjects were considered possible infusion reactions, and 14 of these subjects were withdrawn without repeated administration, officials said.

During the study, the rate of administration was slowed from 30 minutes to 60 minutes, and the infusion volume diluted from 100 mL to 200 mL. Infusion reactions subsequently abated.

The results were presented at the European League Against Rheumatism annual meeting in Amsterdam.

Savient said its phase 3 program is designed to compare the safety and efficacy of Puricase administered by two-hour intravenous infusion every two weeks or every four weeks versus a placebo infusion, over a six-month period.

The program design consists of two replicate six-month placebo-controlled trials of about 100 randomized patients each.

Savient said it licensed exclusive, worldwide rights to the technologies related to Puricase from Duke University of North Carolina and Mountain View Pharmaceuticals, Inc.

Duke developed the recombinant porcine uricase enzyme and Mountain View developed the PEGylation technology.

Mountain View and Duke were granted U.S. and foreign patents covering the licensed technology. Puricase is a registered trademark of Mountain View, officials said.

Savient is an East Brunswick, N.J., specialty pharmaceutical company.

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