MALVERN, Pa., Sept. 10, 2025 /PRNewswire/ -- Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today that two presentations related to plantar fibromatosis (PFI) and plantar fasciitis (PFA) will be shared during the American Orthopaedic Foot & Ankle Society Annual Meeting, taking place September 10-13, 2025.
The presentations cover findings from Phase 1 and Phase 2 studies of collagenase clostridium histolyticum (CCH) in patients with PFA and PFI, respectively.
"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, 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."
The two Endo-supported presentations are below:
- Collagenase Clostridium Histolyticum (CCH) in Patients With Plantar Fibromatosis (PFI): Post Hoc Analysis of a Phase 2, Double-blind, Randomized, Placebo-Controlled Study
- Authors: Saadiq El-Amin, MD, PhD; C. James Anderson, DPM; Ira Gottlieb DPM; Jason Levy, DPM, FACFAS; Sara E. Suttle, DPM, FACFAS; James Tursi, MD; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; Joseph Caporusso, DPM
- A Phase 1, Single-Blind, Randomized, Placebo-Controlled Dose Escalation Study to Assess Collagenase Clostridium Histolyticum (CCH) vs Placebo in Patients With Plantar Fasciitis (PFA)
- Authors: Saadiq El-Amin, MD, PhD; Joseph Caporusso, DPM; Ira Gottlieb, DPM; Jason Levy, DPM, FACFAS; Sara Suttle, DPM, FACFAS; James Tursi, MD; Nigel Jones, PharmD; Luis Ortega, MD; Jeffrey Andrews, MS; C. James Anderson, DPM
CCH is not approved for use in treating patients with PFI or PFA. Endo is currently enrolling patients in the pivotal Phase 3 program for PFI.
About the Phase 2 PFI Study
A post hoc analysis of Phase 2 data identified a subgroup of PFI patients who appeared to respond well to CCH treatment. After excluding certain patients, those treated with CCH showed improvements in pain, nodule hardness, and overall condition compared to placebo. The subgroup also demonstrated greater treatment benefits than the original study population. A Phase 3 trial is currently underway with this refined population.
About the Phase 1 PFA Study
A Phase 1 proof-of-concept study evaluated the safety, tolerability, and effectiveness of a single CCH dose for PFA. The safety profile aligned with known adverse events (AE) and were mostly rated mild to moderate. Higher CCH doses had more frequent and severe AEs. CCH treatment showed improvements across all effectiveness measures compared to placebo, though significance was not assessed. These results supported further investigation in a Phase 2 trial.
About Plantar Fibromatosis
PFI or Ledderhose disease is a hyperproliferative fibrous tissue disorder resulting in the formation of collagen nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot, which is often painful. There is no cure for PFI. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.
About Plantar Fasciitis
PFA causes foot discomfort due to inflammation and degeneration of the tissue connecting the heel to the toes, resulting in prominent heel pain. It is especially noticeable when starting to walk in the morning or after prolonged sitting or standing. There is no cure for PFA. Symptom management options include conservative options such as orthotics, icing, stretching, bracing, over the counter pain and anti-inflammatory medications with surgery reserved for more chronic presentations to relieve the tension in the plantar fascia.
About Endo
Endo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with our products; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Endo's and Mallinckrodt's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov) and Mallinckrodt's website (www.mallinckrodt.com). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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