MALVERN, PA — Endo is presenting new clinical data on collagenase clostridium histolyticum (CCH) as a potential nonsurgical treatment for plantar fibromatosis (PFI) and plantar fasciitis (PFA) during the American Orthopaedic Foot & Ankle Society Annual Meeting, held September 10–13, 2025.
The company is sharing results from a Phase 2 study of CCH in PFI and a Phase 1 trial in PFA, adding to its growing research into treatments for chronic, debilitating foot conditions that currently lack approved therapies.
“We are pleased to share information with the healthcare community on these important data to expand medical knowledge of these painful conditions,” said James Tursi, M.D., Executive Vice President of Global Research & Development at Endo. “We are advancing a Phase 3 study aimed at exploring a potential nonsurgical treatment option for patients with PFI, further demonstrating our commitment to developing medicines that address challenging and burdensome conditions.”
Phase 2 PFI Study
A post hoc analysis of Phase 2 data identified a subgroup of PFI patients who responded favorably to CCH. Those treated showed improvements in pain, nodule hardness, and overall condition compared with placebo, with greater benefits observed in the refined subgroup than in the original study population. A pivotal Phase 3 trial is currently enrolling patients.
Phase 1 PFA Study
In the PFA trial, researchers evaluated the safety and effectiveness of a single CCH dose. The treatment showed improvements across all measures versus placebo, although statistical significance was not assessed. Adverse events were consistent with the drug’s known safety profile and were generally mild to moderate, with higher doses linked to more frequent and severe effects. The findings supported advancing to Phase 2 research.
Understanding PFI and PFA
Plantar fibromatosis, also known as Ledderhose disease, is a rare fibrous tissue disorder that causes painful nodules along the plantar fascia. Treatment options are limited to symptom management, including orthotics, injections, and in severe cases, surgery.
Plantar fasciitis, a more common condition, involves inflammation and degeneration of the plantar fascia, leading to chronic heel pain. Conservative treatments such as stretching, bracing, and anti-inflammatory medications are typically first-line options, with surgery reserved for persistent cases.
While CCH is not currently approved for treating either condition, Endo’s ongoing research highlights its potential role as a novel therapy for patients facing limited and often invasive treatment options.
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