DUBLIN, Ireland I July 1, 2022 I 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. 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).
About Adhesive Capsulitis
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.1 AC is believed to affect from 3% to 5% of the U.S. general population with an incidence of up to 20% in those with diabetes.2
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.3 More invasive management options include nerve blocks, a variety of injection options with varying degrees of efficacy demonstrated and ultimately, hydrodilatation or manipulation under anesthesia (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 anesthesia.3
About Endo
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
References:
- Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004. PMID: 21885699.
- Le HV, Lee SJ, Nazarian A, et al. Adhesive capsulitis of the shoulder: Review of pathophysiology and current clinical treatments. Shoulder & Elbow 2017;9(2):75-84.
- Cho C-H, Bae K-C, Kim D-H. Treatment strategy for frozen shoulder. Clin Orthoped Surg 2019;11:249-257.
SOURCE: Endo International
Post Views: 86
DUBLIN, Ireland I July 1, 2022 I 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. 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).
About Adhesive Capsulitis
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.1 AC is believed to affect from 3% to 5% of the U.S. general population with an incidence of up to 20% in those with diabetes.2
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.3 More invasive management options include nerve blocks, a variety of injection options with varying degrees of efficacy demonstrated and ultimately, hydrodilatation or manipulation under anesthesia (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 anesthesia.3
About Endo
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
References:
- Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004. PMID: 21885699.
- Le HV, Lee SJ, Nazarian A, et al. Adhesive capsulitis of the shoulder: Review of pathophysiology and current clinical treatments. Shoulder & Elbow 2017;9(2):75-84.
- Cho C-H, Bae K-C, Kim D-H. Treatment strategy for frozen shoulder. Clin Orthoped Surg 2019;11:249-257.
SOURCE: Endo International
Post Views: 86
