Auxilium Pharma: First Patient Dosed In Phase 2b Frozen Shoulder Syndrome Trial

(RTTNews) - Auxilium Pharmaceuticals, Inc. (AUXL) said the first patient was dosed in its Phase 2b trial of collagenase clostridium histolyticum or CCH for the treatment of adult patients with adhesive capsulitis, commonly known as Frozen Shoulder syndrome or FSS.

FSS, also known as adhesive capsulitis, can be a prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder and pain. The condition is expected to affect nearly 2 - 5 percent of the general adult population and the full duration of the disease can last from around one year to up to 3.5 years.

Some cases never completely resolve, while the majority of cases are now managed conservatively with prolonged physical therapy and occasionally with steroid injections. It is anticipated that about 300,000 cases of FSS are diagnosed every year and some 10 percent are treated with an invasive intervention such as surgery or manipulation under anesthesia on an annual basis.

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 patients with a palpable cord and in the U.S. as the first Food and Drug Administration approved non-surgical treatment of adult men with Peyronie's disease with a palpable plaque. XIAFLEX includes a combination of two subtypes of collagenase, derived from Clostridium histolyticum.

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 FSS. This would enroll about 300 adult men and women at nearly 35 sites in the U.S. and Australia. The Phase 2b study's primary endpoint is the change from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared with placebo.