The two Phase III pivotal trials assessed the safety and efficacy of a 6-month course of Puricase (pegloticase) therapy in patients with treatment-failure gout, under the auspices of a special protocol assessment from the Food and Drug Administration. Nearly all patients who completed the Phase III trials have opted to enroll in the open label extension, selecting either the every two week, or the every four week 8mg Puricase treatment arms. The open label extension protocol is ongoing. A follow-on open label extension protocol for another twelve months is planned, regardless of whether patients choose to continue to receive Puricase or whether they enter the observation arm of the study.
Christopher Clement, president and CEO, said: “The completion of the in-life portion of the Phase III studies is an important milestone for both the Company and for treatment-failure gout patients. We believe the level of patient commitment during the study period and the high rate of enrollment in our open label extension protocol underscores the critical void in treatment options for patients who suffer from this condition that Puricase may uniquely address. As we move forward over the next several weeks, we will focus our resources on assembling and analyzing the Phase III data. We remain on track to make our next public statement regarding the Phase III studies when we report top-line results in December.”