Auxilium Pharmaceuticals, Inc. has announced that the first patient was dosed in its Phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of adult patients with adhesive capsulitis, commonly known as frozen shoulder syndrome (FSS).
CCH is a biologic approved in the U.S., EU, Canada and Australia under the trade name XIAFLEX for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord and in the U.S. as the first FDA approved non-surgical treatment of adult men with Peyronie’s disease (PD) with a palpable plaque. XIAFLEX consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.
“The initiation of our Phase 2b Frozen Shoulder syndrome study represents another development milestone for Auxilium as we further evolve our pipeline and advance a fourth potential indication for CCH, ” explained Adrian Adams, chief executive officer and president of Auxilium. “We believe that our continued measured investments in research and development, together with the upcoming product launches of XIAFLEX in Peyronie’s disease and STENDRATM in erectile dysfunction, position the company well for growth and shareholder value creation.”
The Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 unilateral idiopathic FSS. The study will enroll approximately 300 adult men and women at approximately 35 sites in the U.S. and Australia. Subjects will be randomized 3:1 to receive CCH or placebo and will receive up to three ultrasound-guided injections of study drug.
“We are very excited to be moving into this next phase of development for CCH in the potential treatment of frozen shoulder, ” said Dr. James Tursi, chief medical officer of Auxilium. “FSS is a condition with no approved therapies and limited treatment options. Innovative treatment approaches such as CCH, if approved by the FDA, may allow patients quicker relief from limits in range of motion and associated pain.”
Adrian Adams told OTW, “While we haven’t provided a specific timeline for the resulting data announcement, these type of Phase 2 trials typically take 12-24 months to complete. We’ll be sharing more details as we near trial completion.”
