BioSpecifics Announces Initiation Of Phase 2b Study Of CCH

(RTTNews) - BioSpecifics Technologies Corp. (BSTC) Friday said its partner Auxilium Pharmaceuticals, Inc. has initiated its Phase 2b study of collagenase clostridium histolyticum indicated for the treatment of frozen shoulder syndrome.

Frozen shoulder, also known as adhesive capsulitis, 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.

"With the recent approval by the U.S. 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, " said Thomas Wegman, President of BioSpecifics.

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 frozen shoulder. 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. Each injection will be separated by a minimum of 21 days.

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.