The results were presented at the European League against Rheumatism (EULAR) 2006 Annual Congress in Amsterdam.
The response rate, defined as the proportion of patients that had a mean serum uric acid level below 6 mg/dL, was over 50% for all dose groups, with the 8 mg/2 week dose group showing over 80% response rate. The analysis also demonstrates that, at all doses tested, the serum uric acid level was maintained in the normal range at least 75% of the time.
According to the company, laboratory assessment of antibody response to Puricase (PEG-uricase) findings was encouraging. The antibody response was primarily of the IgM type and was found to be present prior to dosing in some patients.
“The efficacy results from the phase II are very promising, especially considering that this patient population is one in which conventional therapy already has failed. Additionally, the immunogenicity results presented at EULAR are encouraging, as are the lack of any clinical manifestations of allergy,” said Dr Zeb Horowitz, chief medical officer of Savient.
The company has now moved the compound into larger phase III studies.