Endo announces positive results from phase 2 study of collagenase clostridium histolyticum in participants with adhesive capsulitis of shoulder

Endo International plc 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. Tursi, M.D., 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 shoulder at the Day 95 visit. This adapted scale measures pain and function parameters of the shoulder. Secondary endpoints included measures of passive and active range of motion improvement (PROM and AROM respectively). Adhesive capsulitis (AC) is characterized by a painful and gradual loss of active and passive shoulder motion resulting from fibrosis and contracture of the joint capsule. It is a specific pathologic entity in which chronic inflammation of the joint capsule produces thickening and fibrosis. Patients typically present with pain of insidious onset of several months' duration. AC is believed to affect from 3% to 5% of the US general population with an incidence of up to 20% in those with diabetes. Treatment options include a range of conservative and potentially even surgical measures. Oral and intra-articular corticosteroids have been shown to have a limited benefit in reducing pain and increasing ROM in AC. Physical therapy (PT) to the limit of pain is widely accepted as part of the management of AC, commonly in the early stages of the disease. More invasive management options include nerve blocks, a variety of injection options with varying degrees of efficacy demonstrated and ultimately, hydrodilatation or manipulation under anaesthesia (MUA) may be required. Arthroscopic capsular release has also been used to treat AC often as a last resort, with the associated risks of postoperative pain, recurrent postoperative AC, and axillary nerve damage, as well as the risks associated with general anaesthesia. Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies.

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