The two phase III clinical studies, known as GOUT 1 and GOUT 2, are designed to compare the safety and efficacy of Puricase administered by two-hour intravenous infusion every two weeks or every four weeks versus placebo infusion, over a six-month period. Each study will randomize approximately 100 patients.
“The two GOUT studies now underway at approximately 60 clinical sites in the US, Mexico, and Canada incorporate an innovative design and novel methodologies to demonstrate both uric acid control and attainment of clinical outcomes,” said Dr Zeb Horowitz, chief medical officer.
Puricase has successfully completed phase I and II studies, proving to be safe and well-tolerated with few adverse events. Savient licensed exclusive, worldwide rights to the technologies related to the drug from Duke University of North Carolina and Mountain View Pharmaceuticals.
Gout results from deposits of needle-like crystals of uric acid in connective tissue and in the joints. These deposits lead to inflammatory arthritis, which causes joint swelling, redness, heat, pain, and stiffness and damage to the affected joints.