Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced positive top-line results from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).
In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects (p=0.0005) and a 3.3 point (44%) improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (p=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (p=0.0059) and a 2.4 point (32.4%) improvement in the PDQ bother domain for XIAFLEX subjects (p=0.0496). XIAFLEX was generally well-tolerated. The most common treatment related adverse events reported in the phase III studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection site hematoma, pain and swelling. If approved by the U.S. Food and Drug Administration (FDA), XIAFLEX is expected to be the first and only approved biologic therapy indicated for the treatment of PD.
"We believe that XIAFLEX, if approved for the treatment of Peyronie's Disease, has the clinical profile to become a potential breakthrough procedure," said Adrian Adams, Auxilium's Chief Executive Officer and President. "With its current indication in Dupuytren's contracture, positive topline clinical results in Peyronie's Disease, and development ongoing in Frozen Shoulder syndrome and cellulite, XIAFLEX represents a pipeline in a product with potential applications in multiple therapeutic areas that currently have limited options."