Endo, Inc. presented data from a Phase 2 clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis at the American Orthopaedic Foot & Ankle Society (AOFAS) annual scientific meeting. The results suggest a potential benefit of CCH in managing this challenging condition.
The Phase 2 double-blind, randomized, placebo-controlled study assessed the efficacy and safety of CCH versus placebo in patients with plantar fibromatosis. The study's findings offer hope for a non-surgical treatment option for a condition that currently lacks a definitive cure.
Phase 2 Study Results
The results of the Phase 2 study indicated a trend in CCH treatment effect over placebo in reducing pain associated with plantar fibromatosis, as measured by the Foot Function Index Total Pain subscale score. Furthermore, the study demonstrated nominally significant improvements with CCH compared to placebo in the investigator's assessment of improvement, nodular hardness (measured by durometer), and nodule consistency (firmness) via palpation.
The safety profile of CCH was consistent with previous studies, with most adverse events being local and rated as mild to moderate. Notably, there were no reported treatment-related serious adverse events.
About Plantar Fibromatosis
Plantar fibromatosis (PFI), also known as Ledderhose disease, is a proliferative fibrous tissue disorder characterized by the formation of nodules along the plantar fascia. These nodules can cause significant pain and discomfort, impacting a patient's ability to walk and perform daily activities. Current treatment options are limited to symptom management, including custom insoles, topical treatments, pain medication, steroid injections, radiation therapy, and surgical removal of the nodules.
Endo's Musculoskeletal Pipeline
"Our clinical programs for plantar fibromatosis and plantar fasciitis are key elements of our future musculoskeletal pipeline indications, and we are pleased to share information with the medical community on these important data," said James P. Tursi, MD, Executive Vice President, Global Research & Development at Endo. Endo is currently enrolling patients in a pivotal Phase 3 program to further evaluate CCH for the treatment of plantar fibromatosis.
CCH is not yet approved for use in treating patients with plantar fibromatosis. The ongoing Phase 3 program aims to provide further evidence of its efficacy and safety for this indication.
