Endo, Inc. presented data from Phase 1 and Phase 2 clinical studies evaluating collagenase clostridium histolyticum (CCH) for the treatment of plantar fibromatosis at the American Society of Podiatric Surgeons (ASPS) Surgical Conference on October 18-19, 2024. The presentations highlighted the potential of CCH in addressing this challenging condition.
Phase 2 Study Results
The Phase 2 study, a double-blind, randomized, placebo-controlled trial, assessed the efficacy and safety of CCH in patients with plantar fibromatosis. Results demonstrated a trend towards pain reduction with CCH compared to placebo, as measured by the Foot Function Index Total Pain subscale score. Furthermore, the study showed nominally significant improvements in investigator assessments of overall improvement, nodule hardness (durometer), and nodule consistency (firmness by investigator palpation) scales.
Phase 1 Study Results
The Phase 1 dose-ranging study evaluated the safety and tolerability of CCH in patients with plantar fibromatosis. The study reported improvements in nodule hardness and in patient and physician satisfaction scores. The safety profile of CCH in this study was consistent with previous clinical trials, with most adverse events rated as mild to moderate and no treatment-related serious adverse events reported.
Current Treatment Landscape and Endo's Phase 3 Trial
Plantar fibromatosis, also known as Ledderhose disease, is a hyperproliferative fibrous tissue disorder causing painful nodules along the plantar fascia. Current treatments focus on symptom management, including custom insoles, topical treatments, pain medications, steroid injections, and surgery. There is currently no cure for plantar fibromatosis.
Endo is currently enrolling patients in a pivotal Phase 3 program to further investigate CCH as a potential treatment for plantar fibromatosis. CCH is not yet approved for this indication.
Expert Commentary
"We're pleased to share data with healthcare providers about our plantar fibromatosis clinical trials to help improve patient care and discuss our clinical development program," said James P. Tursi, M.D., Executive Vice President, Global Research & Development at Endo. "These presentations also demonstrate our growth strategy to develop a musculoskeletal pipeline serving those suffering from this and other burdensome conditions."
