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DUBLIN, July 1, 2022 /PRNewswire/ — Endo International plc (NASDAQ:ENDP) today announced top-line results from its Phase 2 study of Collagenase Clostridium Histolyticum (or “CCH”) in participants with adhesive capsulitis (AC) of the shoulder, commonly known as “frozen shoulder.” While Phase 2 study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the Day 95 visit, the difference compared to those study participants receiving placebo was not statistically significant. The safety profile of CCH in the Phase 2 study was consistent with the known safety profile from other studies. Most treatment-emergent adverse events were of mild to moderate severity with the most common events following treatment with CCH being injection site bruising, arthralgia , injection site pain, injection site swelling and contusion.
“We are disappointed in the study outcome, and based on these data, we will be reevaluating our path forward for CCH for the treatment of adhesive capsulitis of the shoulder. We will continue focusing on our pipeline, including with respect to other potential CCH indications ,” said James P. TursiMD, Executive Vice President, Global Research & Development at Endo. “We are committed to advancing our strategic priority of expanding and enhancing our portfolio for growth.”
The Phase 2 trial enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized 1:1 to receive CCH or placebo administered by ultrasound-guided injection. Participants received up to 3 injections separated by a minimum of 21 days. Participants completed standard home exercises and received physical therapy at designated time points during the study.
The Phase 2 trial’s primary endpoint was the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected …
Full story available on Benzinga.com
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