Endo Shares Data at AOFAS Annual Meeting

Endo, Inc. (OTCQX: NDOI) has announced that findings from a clinical study on collagenase clostridium histolyticum (CCH) for treating plantar fibromatosis were shared at the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting, which concludes on September 14, 2024.

James P. Tursi, MD, Executive Vice President of Global Research & Development at Endo, emphasized the importance of their clinical programs for plantar fibromatosis and plantar fasciitis as integral components of their future musculoskeletal pipeline. The data presented in the meeting highlights the progress in these critical areas, offering valuable insights to the medical community.

The presentation focused on data from a Phase 2 clinical trial that evaluated the efficacy of CCH in patients suffering from plantar fibromatosis. This study was a double-blind, randomized, placebo-controlled trial designed to compare the effects of CCH with a placebo. The study involved several notable authors including Joseph Caporusso, DPM; Ira Gottlieb, DPM; Jason Levy, DPM, FACFAS; Saadiq El-Amin, MD; Sara E. Suttle, DPM, FACFAS; James Tursi, MD; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; and C. James Anderson, DPM.

The results from the Phase 2 study indicated a notable trend favoring CCH over placebo in reducing pain related to plantar fibromatosis, as measured by the Foot Function Index Total Pain subscale score. Additionally, the study showed significant improvements with CCH compared to placebo in several areas: investigator assessments of condition improvement, nodular hardness measured with a durometer, and the consistency of nodules as determined by investigator palpation.

The safety profile of CCH observed in this study was consistent with known safety data from previous clinical trials involving CCH. Most adverse reactions were local and ranged from mild to moderate in severity. Importantly, there were no serious adverse events related to the treatment reported during the study.

It is important to note that CCH is not yet approved for the treatment of plantar fibromatosis. However, Endo is actively recruiting patients for a pivotal Phase 3 program, aiming to further evaluate the efficacy and safety of CCH in this condition.

Plantar fibromatosis, also known as Ledderhose disease, is characterized by the excessive formation of fibrous tissue leading to painful nodules along the plantar fascia, the thick connective tissue supporting the foot's arch. Currently, there is no cure for this condition. Management of symptoms typically involves custom insoles, topical treatments, over-the-counter pain relievers, anti-inflammatory medications, radiation therapy, steroid injections, and, in some cases, surgery to remove the nodules.

Endo, Inc. is a specialized pharmaceutical company dedicated to transforming scientific insights into therapies that enhance quality of life. The company’s team collaborates passionately to develop and deliver essential medications, aiming to improve the lives of those they serve.