Endo Presents Plantar Fibromatosis and Plantar Fasciitis Data at the American Podiatric Medical Association Annual Meeting
Endo (OTCQX: NDOI) announced three presentations at the American Podiatric Medical Association Annual Meeting from July 24-27, 2025, focusing on plantar fibromatosis (PFI) and plantar fasciitis (PFA) research. The presentations include findings from Phase 1 and Phase 2 studies of collagenase clostridium histolyticum (CCH) and a retrospective patient analysis.
The company is currently advancing a Phase 3 study investigating CCH as a potential nonsurgical treatment for PFI patients. The research presentations cover clinical trial data, patient experiences, and dose escalation studies, demonstrating Endo's commitment to developing treatments for challenging conditions.
Endo (OTCQX: NDOI) ha annunciato tre presentazioni al Congresso Annuale dell'American Podiatric Medical Association, che si terr脿 dal 24 al 27 luglio 2025, con un focus sulla ricerca sulla fibromatosi plantare (PFI) e sulla fascite plantare (PFA). Le presentazioni includeranno i risultati degli studi di Fase 1 e Fase 2 sulla collagenasi clostridium histolyticum (CCH) e un'analisi retrospettiva dei pazienti.
L'azienda sta attualmente portando avanti uno studio di Fase 3 che indaga l'uso della CCH come possibile trattamento non chirurgico per i pazienti con PFI. Le presentazioni di ricerca copriranno dati da studi clinici, esperienze dei pazienti e studi di escalation del dosaggio, dimostrando l'impegno di Endo nello sviluppo di terapie per condizioni complesse.
Endo (OTCQX: NDOI) anunci贸 tres presentaciones en la Reuni贸n Anual de la American Podiatric Medical Association, que se llevar谩 a cabo del 24 al 27 de julio de 2025, centradas en la investigaci贸n sobre fibromatosis plantar (PFI) y fascitis plantar (PFA). Las presentaciones incluyen hallazgos de los estudios de Fase 1 y Fase 2 de la colagenasa clostridium histolyticum (CCH) y un an谩lisis retrospectivo de pacientes.
La compa帽铆a est谩 avanzando actualmente en un estudio de Fase 3 que investiga la CCH como un posible tratamiento no quir煤rgico para pacientes con PFI. Las presentaciones de investigaci贸n abarcan datos de ensayos cl铆nicos, experiencias de pacientes y estudios de escalada de dosis, demostrando el compromiso de Endo en desarrollar tratamientos para condiciones complejas.
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Endo (OTCQX : NDOI) a annonc茅 trois pr茅sentations lors de la r茅union annuelle de l'American Podiatric Medical Association, qui se tiendra du 24 au 27 juillet 2025, ax茅es sur la recherche sur la fibromatose plantaire (PFI) et la fasciite plantaire (PFA). Les pr茅sentations incluent les r茅sultats des 茅tudes de phase 1 et phase 2 sur la collag茅nase Clostridium histolyticum (CCH) ainsi qu'une analyse r茅trospective des patients.
L'entreprise m猫ne actuellement une 茅tude de phase 3 茅valuant la CCH comme traitement non chirurgical potentiel pour les patients atteints de PFI. Les pr茅sentations de recherche couvriront les donn茅es des essais cliniques, les exp茅riences des patients et les 茅tudes d'escalade de dose, d茅montrant l'engagement d'Endo 脿 d茅velopper des traitements pour des pathologies complexes.
Endo (OTCQX: NDOI) gab drei Pr盲sentationen auf der Jahrestagung der American Podiatric Medical Association vom 24. bis 27. Juli 2025 bekannt, die sich auf die Forschung zu plantarer Fibromatose (PFI) und Plantarfasziitis (PFA) konzentrieren. Die Pr盲sentationen umfassen Ergebnisse aus Phase-1- und Phase-2-Studien zur Kollagenase Clostridium histolyticum (CCH) sowie eine retrospektive Patientenanalyse.
Das Unternehmen f眉hrt derzeit eine Phase-3-Studie durch, die CCH als potenzielle nicht-chirurgische Behandlung f眉r PFI-Patienten untersucht. Die Forschungspr盲sentationen umfassen klinische Studiendaten, Patientenerfahrungen und Dosiseskalationsstudien, was Endos Engagement bei der Entwicklung von Therapien f眉r herausfordernde Erkrankungen unterstreicht.
- None.
- CCH is not yet approved for PFI or PFA treatment
The first two presentations cover findings from Phase 1 and Phase 2 studies of collagenase clostridium histolyticum (CCH) in patients with PFA and PFI, respectively, while a third presentation features a retrospective analysis of insights from patients with PFI.
"We're pleased to share clinical trial data with healthcare providers as part of our ongoing efforts to help improve patient care and highlight our clinical development strategy," said James P. 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 three 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: C. James Anderson, DPM; Ira Gottlieb DPM; Jason Levy, DPM, FACFAS; Saadiq El-Amin, MD, PhD; Sara E. Suttle, DPM, FACFAS; James Tursi, MD; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; Joseph Caporusso, DPM
- Understanding the Lived Experiences of People With Plantar Fibromatosis (PFI): A Mixed Methods Study
- Authors: Joseph Caporusso, DPM; David Hurley, MD; Carrie Lewis, MS; Gary Manley, BSc; Laura Iliescu, MSc; and Luis Ortega, MD
- 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: Joseph Caporusso, DPM; Ira Gottlieb, DPM; Jason Levy, DPM; Saadiq El-Amin, MD, PhD; Sara Suttle, DPM; 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 PFI Retrospective Analysis
The retrospective analysis of 91 patients synthesizes three patient voice studies, revealing that individuals with PFI are experiencing varying degrees of pain鈥攖hose reporting moderate to severe pain face greater physical, emotional, and daily life burdens. Participants expressed dissatisfaction with current treatments and a strong interest in nonsurgical options like collagenase clostridium histolyticum, highlighting a need for therapies that reduce or halt nodule growth.
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聽is a diversified pharmaceutical company 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聽www.endo.com聽or connect with us on聽LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Dr. Tursi and any statements relating 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. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: clinical trial results; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the proposed business combination transaction between Endo and Mallinckrodt. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the
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FAQ
What did Endo (NDOI) present at the American Podiatric Medical Association Annual Meeting 2025?
What is the status of Endo's clinical trials for plantar fibromatosis (PFI)?
Is CCH approved for treating plantar fibromatosis or plantar fasciitis?
What type of treatment is Endo developing for plantar fibromatosis?
