Patients in the study are randomized on a 2:1 basis in favor of Xiaflex treatment. To qualify for the study, patients must have at least 20 degrees of contracture. The primary endpoint of the study is to determine if Xiaflex can reduce the contracture angle of the primary joint to within 0 to 5 degrees of normal after up to three injections of Xiaflex.
Upon completion of the double-blind study, all patients are eligible to be enrolled in a separate open label extension study in which the patient will receive active drug if they were initially given placebo and/or they have the opportunity to have other affected joints treated. Data from the double-blind study and the open label extension study will form the basis of 12-month follow-up information to be used in the biologics license application for marketing approval of Xiaflex submitted to the FDA.
The Australian study is a double-blind, randomized, placebo-controlled study and follows a protocol similar to that of the US study and its open label extension.
In accordance with the study design, all enrolled patients have received their first injection of either Xiaflex or placebo. Due to the high level of interest from patients and physicians, the company was able to exceed its enrollment targets in both studies, with greater than 300 patients enrolled in both studies. The company had targeted enrolling 216 patients in the US study and 60 patients in the Australian study.
Armando Anido, CEO and president of Auxilium, said: “We continue to believe that we will report top line efficacy results from these two trials in the second quarter of 2008 and that we are on track to file a biologics license application with the FDA in early 2009.”