Auxilium has reported top-line efficacy and safety results for the phase IIb clinical trial for Xiaflex (collagenase clostridium histolyticum) in the treatment of peyronie’s disease. The phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients’ sexual quality of life using the company’s peyronie’s disease Patient Reported Outcome (PRO) questionnaire.
Overall, Xiaflex demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvature (p=0.001) and the PRO peyronie’s disease bother domain (p=0.046). Xiaflex was well-tolerated and the most common treatment related adverse events in the phase IIb study were consistent with adverse events reported in previous peyronie’s disease trials with Xiaflex, which included injection site bruising, edema and pain.
Armando Anido, president and chief executive officer of Auxilium, said: “We believe the results from this trial provide a meaningful step forward to a better understanding of the treatment of peyronie’s disease with Xiaflex. We expect to meet with the FDA in the second quarter of 2010 to discuss a proposed phase III plan that potentially could be started in the second half of 2010.”
A total of 145 patients evaluable for efficacy enrolled in 12 clinical sites across the US, with 109 patients receiving Xiaflex as a series of intralesional injections and 36 receiving placebo (3:1 ratio) in the study. The treatment and placebo arms were also randomized to test for a benefit with the addition of penile modeling versus no modeling (1:1). Modeling refers to massaging of the plaque and is intended to maximize the enzymatic effect of the Xiaflex injection in the plaque.
Laurence Levine, investigator and professor of department of urology at Rush University Medical Center, said: “Xiaflex has shown a sustained benefit at 36 weeks versus placebo for patients suffering from peyronie’s disease. The drug had a statistically significant reduction in penile curvature and demonstrated statistically significant improved quality of life for patients as measured by the PRO domain for peyronie’s disease bother. Getting these efficacy results without the risks of surgical intervention would be an enormous advantage for patients suffering from peyronie’s disease.”