Xiaflex collagenase clostridium histolyticum: Phase IIb data
Top-line data from a U.S. Phase IIb trial in 145 patients showed that Xiaflex significantly improved penile curvature from baseline to week 36 by 29.7% vs. 11% for placebo (p=0.001). Xiaflex also significantly improved the PRO Peyronie's disease bother domain from baseline to week 36 vs. placebo (p=0.046), but did not significantly improve mean scores in the PRO penile pain, intercourse discomfort or intercourse constraint domains vs. placebo. Additionally, 60.5% of patients treated with Xiaflex (n=109) achieved at least a 25% reduction in angle of curvature vs. 25% for placebo.
In a prospective subgroup of patients who received penile massaging of the collagen plaque on the shaft, which is intended to maximize the enzymatic effect of the compound, Xiaflex plus penile massaging significantly improved penile curvature by 32.4% vs. a 2.5% worsening for placebo plus penile massaging (p<0.001). Xiaflex without penile massaging did not significantly improve penile curvature vs. placebo (p=0.91). Xiaflex plus penile massaging also significantly improved the PRO Peyronie's disease bother domain vs. placebo plus penile massaging (p=0.004), whereas Xiaflex without penile massaging did not significantly improve any of the PRO domains vs. placebo. ...