Endo Reveals Innovative Research on Plantar Conditions at AOFAS Annual Meeting

Endo's Presentation at AOFAS Annual Meeting

The American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting, held from September 10-13, 2025, spotlighted significant advancements in understanding plantar fibromatosis (PFI) and plantar fasciitis (PFA). Endo, a subsidiary of Mallinckrodt plc, showcased key findings from two pivotal studies focusing on collagenase clostridium histolyticum (CCH), a potential treatment for these painful foot conditions.

Overview of Presentations

Study on Plantar Fibromatosis

The first presentation examined a post hoc analysis derived from a Phase 2, double-blind, randomized, placebo-controlled study. The analysis, led by Dr. Saadiq El-Amin and his team, identified a subset of PFI patients who benefitted from CCH treatment. Despite exclusions within the population, the results indicated significant improvements in pain levels, nodule hardness, and overall condition compared to placebo. This subgroup demonstrated enhanced treatment outcomes, offering insights into refining future clinical approaches. The need for a Phase 3 trial is now pressing, focusing on this identified subgroup to further validate these promising results.

Investigation into Plantar Fasciitis

The second presentation focused on a Phase 1, single-blind, randomized, placebo-controlled trial aimed at assessing the safety, tolerability, and effectiveness of a single dose of CCH for treating PFA. The research team reported that the safety profile of CCH was in line with known adverse effects, predominantly mild to moderate. Importantly, the findings suggested that while the CCH treatment group showed improvements across effectiveness metrics, they stressed the necessity of further evaluation through a Phase 2 trial to validate these outcomes.

Insights from Endo’s Executive Team

James Tursi, M.D., Executive Vice President of Global Research and Development at Endo, described the presentations as pivotal in enhancing medical knowledge surrounding these debilitating conditions. He expressed the company's commitment to advancing non-invasive treatment options for PFI, benefiting patients grappling with chronic pain and mobility challenges. Endo aims to not only improve patient outcomes but also raise awareness within the healthcare community about these conditions.

Understanding Plantar Fibromatosis and Plantar Fasciitis

Both PFI and PFA are prominent yet understudied foot conditions.

Plantar Fibromatosis

PFI, often referred to as Ledderhose disease, leads to painful collagen nodule formation along the plantar fascia, which supports the foot's arch. Unfortunately, there is no definitive cure for PFI. Currently, symptom management options include custom orthotics, topical treatments, over-the-counter medications, radiation therapy, steroid injections, and, as a last resort, surgery.

Plantar Fasciitis

Conversely, PFA causes inflammation and degeneration in connective tissue, resulting in pronounced heel pain. Symptoms often arise during initial morning movements or following extended periods of inactivity. Similar to PFI, treatment avenues focus on conservative measures that may involve orthotics, stretching, icing, bracing, and use of over-the-counter medication, reserving surgery for severe or chronic cases.

Future Directions

Endo is rapidly enrolling patients for their pivotal Phase 3 clinical program related to PFI and hopes to further explore the effectiveness of CCH for patients suffering from this challenging disorder. With ongoing research and enthusiasm for innovative treatments, Endo remains dedicated to fostering advancements that hold promise for those living with plantar conditions.

Endo's commitment exemplifies a broader trend in the pharmaceutical industry, showcasing the importance of continued research and the pursuit of non-surgical treatment options for chronic conditions.

About Endo

Endo is committed to transforming insights into life-enhancing therapies and developing essential medicines carefully tailored to meet patient needs. By partnering with medical professionals and fostering innovation, Endo aims to significantly improve the quality of life for those suffering from various health conditions. To discover more about Endo's initiatives, visit www.endo.com.