The open-label, controlled dose-ranging study evaluated CCH’s safety and efficacy in treating Stage 2 unilateral idiopathic FSS against an exercise-only control group.
The change (in degrees) from baseline to the day 92 follow-up in active forward flexion in the affected shoulder compared to the exercise-only cohort was the primary endpoint.
Auxilium chief executive officer and president Adrian Adams said, "Positive top-line data from our phase IIa Frozen Shoulder Syndrome clinical trial represent another very encouraging development milestone for Auxilium as we advance a fourth potential indication of CCH, further diversifying our evolving pipeline."
Statistically significant improvements in range of motion compared to exercise-only arm and dose response were observed.
Positive trends with improvement in degrees in other active range of motion (AROM) assessments compared to the exercise-only group were also reported.
Auxilium chief medical officer Dr. James Tursi said, "We look forward to advancing the clinical development of CCH in Frozen Shoulder syndrome and are currently assessing options to determine the safest and optimal path forward in development."
Localized bruising, injection site pain and swelling, hematoma, and musculoskeletal pain were the most commonly observed treatment-related adverse events with CCH while no drug-related serious adverse events were noted in the study.