BioSpecifics Technologies has reported top-line efficacy and safety results from a Phase 2b clinical trial of Xiaflex for the treatment of peyronie’s disease. The Phase 2b study, conducted by the company’s partner, Auxilium Pharmaceuticals (Auxilium).
The study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients’ sexual quality of life using the peyronie’s disease Patient Reported Outcome (PRO) questionnaire.
The Phase 2b study was a randomised, double-blind, placebo-controlled trial that was designed to assess the safety and efficacy of Xiaflex when administered two times a week, every six weeks, for up to three treatment cycles (2 x 3). The study was conducted at 12 sites throughout the US, and 145 patients were monitored for 36 weeks following the first injection, with 109 patients receiving Xiaflex as a series of intralesional injections and 36 receiving placebo in the study.
The company said that the treatment and placebo arms were also randomised to test for a benefit with the addition of penile modeling versus no modeling. Modeling refers to massaging of the plaque and is intended to maximise the enzymatic effect of the Xiaflex injection in the plaque.
In the study, overall, Xiaflex demonstrated a statistically change compared to placebo at 36 weeks in both improvement in penile curvature and the PRO peyronie’s disease bother domain. There was no statistically change in mean scores between Xiaflex and placebo in the PRO penile pain, intercourse discomfort or intercourse constraint domains. The study result shows Xiaflex was well-tolerated.
In patients who received Xiaflex, a mean improvement of 29.7% in penile curvature from baseline to 36 weeks was seen vs an 11.0% mean improvement in curvature seen in placebo patients. In patients who received Xiaflex, 60.5% of patients achieved the endpoint of at least a 25% reduction in angle of curvature vs 25.0% of placebo patients achieving at least a 25% reduction in angle of curvature.
Reportedly, in the PRO peyronie’s disease bother domain, the overall Xiaflex treatment arm experienced a benefit in mean change in score from baseline to 36 weeks that was significantly better than the overall placebo arm benefit. Auxilium expects to meet with the FDA in the second quarter of 2010 to further discuss these results.
Thomas Wegman, president of BioSpecifics, said: “We look forward to progress in the clinical program for Xiaflex in Peyronie’s disease in 2010.”