Clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis

Endo, Inc. (“Endo”) (OTCQX: NDOI) announced today that data from a clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis were presented during the American Orthopaedic Foot & Ankle Society’s (AOFAS) annual scientific meeting, taking place through September 14, 2024.

“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.

The oral presentation covered data from the Phase 2 clinical study of CCH in patients with plantar fibromatosis.

• A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess Collagenase Clostridium Histolyticum vs Placebo in Patients With Plantar Fibromatosis

  • Authors: 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; C. James Anderson, DPM

The results of the Phase 2 plantar fibromatosis study demonstrated a trend in CCH treatment effect over placebo for reducing pain associated with the condition as measured by the Foot Function Index Total Pain subscale score, as well as nominally significant improvements of CCH versus placebo in the investigator assessment of improvement of the condition, nodular hardness measured by durometer, and nodule consistency (firmness) by investigator palpation. In addition, the CCH safety profile was consistent with the known CCH safety profile from other clinical studies and indications. Most adverse events were local, rated as mild to moderate, and there were no reported treatment-related serious adverse events.

CCH is not approved for use in treating patients with plantar fibromatosis or plantar fasciitis. Endo is currently enrolling patients in the pivotal Phase 3 program.

This article is based on a press release from Endo.