Keenova Eyes New Frontier for Painful Foot Condition with Phase 3 Trial

DUBLIN, Ireland – February 16, 2026 – Pharmaceutical company Keenova Therapeutics has unveiled new research that shines a harsh light on the frustrating treatment journey for patients with plantar fibromatosis, a rare and often painful foot condition. The study, published in the peer-reviewed The Journal of Foot and Ankle Surgery, analyzes real-world treatment patterns and underscores a significant unmet need for effective, nonsurgical therapies.

The publication comes as Keenova advances a Phase 3 clinical trial for a potential first-in-class injectable treatment, positioning the company at the forefront of innovation for a condition that has long lacked effective options beyond invasive surgery.

The Painful Reality of Ledderhose Disease

Plantar fibromatosis, also known as Ledderhose disease, is a progressive disorder characterized by the formation of hard, fibrous nodules along the plantar fascia—the thick band of tissue that runs across the bottom of the foot. While the nodules themselves are benign, they can grow over time, causing significant pain, limiting mobility, and making simple acts like walking or standing an excruciating ordeal. For the thousands of individuals affected, the path to relief is often a dead end.

Currently, there are no FDA-approved nonsurgical treatments specifically for this condition, leaving patients and clinicians with a limited and often ineffective toolkit. Initial conservative treatments typically focus on symptom management rather than addressing the underlying cause. These include custom shoe orthotics designed to offload pressure, physical therapy, and anti-inflammatory medications. While these may provide temporary comfort, they do little to halt the progression of the disease.

More targeted approaches, such as corticosteroid injections, may offer temporary reduction in nodule size and pain, but their effects often wane, and recurrence is common. This leads many patients down the path to surgery, which is considered a last resort. Surgical excision, however, is fraught with its own challenges. Local removal of nodules carries a staggering recurrence rate that can be as high as 100%, while a more aggressive total fasciectomy—the removal of the entire plantar fascia—has a lower recurrence rate of around 25% but introduces risks of painful scarring, nerve damage, and permanent changes to the foot's biomechanics.

Keenova's newly published research confirms this difficult reality. The study found that even after surgery, patients often continue to receive conservative treatments, suggesting that symptoms and the disease itself frequently persist or return. This cycle of ineffective treatment highlights a critical gap in care that Keenova aims to fill.

A Targeted Enzymatic Approach

At the heart of Keenova's strategy is collagenase clostridium histolyticum (CCH), an enzyme with a proven track record in treating other fibrotic conditions. Marketed as Xiaflex for its approved indications, CCH is already used to treat Dupuytren's contracture in the hand and Peyronie's disease—conditions that, like plantar fibromatosis, are characterized by an overproduction of collagen.

The mechanism of CCH is elegantly simple: it is an enzyme that specifically targets and breaks down the excess collagen that forms the hard nodules, offering a non-surgical method to directly address the root of the problem. While used off-label for plantar fibromatosis in some case studies, its efficacy and safety for this specific indication have not been formally established through rigorous, large-scale trials—until now.

Keenova is currently deep into its Phase 3 clinical trial, known as the STRIDE study (NCT06151197), to evaluate CCH for plantar fibromatosis. This randomized, placebo-controlled study is designed to definitively assess the efficacy, safety, and tolerability of the injectable treatment. With an estimated primary completion date of March 2026, the timing of Keenova's announcement suggests that pivotal data may be on the horizon.

"We believe patients with this rare condition deserve more treatment options, especially those seeking alternatives to surgery," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova, in the company's press release. "That's why we are actively investigating a nonsurgical approach in our Phase 3 clinical trial, with the goal of supporting patient care and helping to improve quality of life for the people who need it most."

Data-Driven Strategy in a Niche Market

Keenova's pursuit of a treatment for plantar fibromatosis is a textbook example of a modern, data-driven strategy in the pharmaceutical industry. By first commissioning and publishing a real-world evidence study, the company has built a powerful, evidence-based case for the unmet medical need. This approach not only validates their clinical development program but also provides crucial data that will be essential when engaging with regulatory bodies like the FDA and, eventually, with payers.

The manuscript, titled "Real-World Treatment Patterns Among Newly Diagnosed Patients With Plantar Fibromatosis in the United States," demonstrates that while the condition is rare, it is consistently diagnosed and treated, confirming a clear and present patient population. This strategic use of real-world data de-risks the significant investment required for a Phase 3 trial and highlights the commercial opportunity.

Targeting a rare or "orphan" disease like plantar fibromatosis offers distinct advantages. While the patient pool is smaller than for common ailments, the lack of any approved nonsurgical competitors creates a clear path to market leadership. If successful, Keenova's CCH treatment would not just be another option; it would establish the standard of care, capturing a niche but valuable market.

As the medical community and patients await the final results from the STRIDE trial, Keenova's research provides a solid foundation of evidence for why a new approach is so desperately needed. If the Phase 3 data proves positive, the injectable therapy could represent a paradigm shift in the management of Ledderhose disease, offering meaningful relief without the scalpel and the high risk of recurrence that has long plagued surgical options. For those living with the daily pain and frustration of this condition, this data-driven pursuit offers the most significant hope in decades for a future with less pain and better mobility.