BioSpecifics Technologies Corp, a biopharmaceutical company developing first in class collagenase-based products, has announced that its partner Auxilium Pharmaceuticals, Inc. (Auxilium) has dosed the first patient in its phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of frozen shoulder syndrome (adhesive capsulitis). Frozen shoulder is a clinical syndrome of pain and decreased motion in the shoulder joint thought to be caused by increased capsular collagen thickening and subsequent capsular contraction.
"We believe that there is significant potential for CCH in this indication as approximately 700,000 patients visit a physician each year with symptoms of frozen shoulder syndrome," commented Thomas L Wegman, president of BioSpecifics. "With the recent approval by the US Food and Drug Administration of Xiaflex as a treatment for Peyronie's disease, the potential of collagenase as an effective treatment for many important conditions and diseases is becoming more and more evident. We look forward to exploring its efficacy in additional indications including cellulite, human and canine lipomas as well as uterine fibroids."
As reported by Auxilium, the Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic frozen shoulder. The study will enroll approximately 300 adult men and women at approximately 35 sites in the US 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. Each injection will be separated by a minimum of 21 days. All subjects will also perform home shoulder exercises after the first injection.
The primary endpoint of the phase 2b study will be change in degrees from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo. Patients will also be assessed using the American Shoulder and Elbow Surgeons (ASES) Scale for function and pain as well as additional patient reported outcome measures. Safety assessments will be made during all study visits and immunogenicity testing will be performed at screening and at the end of the study.
Frozen shoulder syndrome is a clinical syndrome of pain and decreased motion in the shoulder joint that is estimated to affect 20 to 50 million people worldwide with a slightly higher incidence in women. Currently, the most common treatments for frozen shoulder syndrome are extensive physical therapy, corticosteroids and/or arthroscopy, as well as certain pain drugs.