Keenova Reports Positive Phase 3 Results for Xiaflex in Plantar Fibromatosis

Xiaflex Shows Strong Results in Late-Stage Clinical Trial

Keenova Therapeutics plc has announced positive topline results from its Phase 3 clinical trial evaluating Xiaflex (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis.

Plantar fibromatosis is a chronic condition in which hard collagen nodules develop in the tissue that supports the arch of the foot. These nodules can cause pain, make walking difficult, and reduce a person's quality of life.

The company said the study successfully met its primary and key secondary goals, bringing Xiaflex one step closer to becoming a potential treatment option for patients with this condition.

Study Meets Primary Endpoint

The Phase 3 trial achieved its primary endpoint by showing a statistically significant and clinically meaningful reduction in foot pain compared with placebo.

Researchers measured pain using the Average Daily Pain Intensity score on the Numeric Rating Scale (NRS). Patients who received Xiaflex experienced greater pain relief than those who received placebo.

The study also met important secondary endpoints related to foot function and daily activities.

Patients Showed Better Foot Function

Besides reducing pain, Xiaflex also helped improve foot function.

The trial reported significant improvements in several patient-reported outcomes, including:

• Better scores on the Foot Function Index (FFI)
• Reduced pain during daily activities
• Improved ability to perform normal movements
• Higher treatment satisfaction
• Better overall assessment of disease severity
• Improvement in the size and characteristics of the foot nodules

These results suggest that the treatment may offer benefits beyond pain relief by helping patients move more comfortably in everyday life.

Safety Profile Remained Consistent

According to Keenova, Xiaflex continued to demonstrate a safety profile that was consistent with its already approved uses.

Most side effects reported during the study were classified as mild to moderate by investigators.

The company also confirmed that no treatment-related serious adverse events were reported during the trial.

FDA Submission Planned Later This Year

Following these positive results, Keenova plans to submit a regulatory application to the US Food and Drug Administration (FDA) during the fourth quarter of 2026.

Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova, said the company is encouraged by the study results because patients currently have very limited treatment options beyond symptom management or surgery.

He added that the company hopes to expand the approved uses of Xiaflex and provide a new treatment option for people living with plantar fibromatosis.

Market Opportunity for Xiaflex

Keenova believes there is a significant unmet medical need in plantar fibromatosis.

Based on healthcare claims data and market projections, the company estimates that around 300,000 people in the United States will seek medical care for the condition in 2028, the year it expects Xiaflex could become available for this indication if approved.

How the Phase 3 Study Was Conducted

The Phase 3 study, known as EN3835-309, was a randomized, double-blind, placebo-controlled clinical trial.

A total of 436 participants with plantar fibromatosis were enrolled.

To qualify for the study, participants needed to have at least one measurable, hard or firm fibrous nodule in the plantar fascia.

Patients were randomly assigned to receive either Xiaflex or placebo.

Each participant could receive up to two treatments, with at least 28 days between each treatment.

Researchers monitored pain every day using the Numeric Rating Scale while also collecting information through several patient questionnaires that evaluated:

• Foot pain
• Physical function
• Walking ability
• Overall disease severity
• Patient satisfaction
• Overall improvement

These assessments helped researchers understand both pain relief and improvements in daily life.

What Is Plantar Fibromatosis?

Plantar fibromatosis, also known as Ledderhose disease, is a rare connective tissue disorder that causes collagen-rich nodules to form along the plantar fascia.

The condition gradually progresses over time and can make standing and walking painful.

Many patients also experience reduced mobility and a lower quality of life.

At present, there are no approved drug treatments specifically for plantar fibromatosis.

Current treatment options mainly focus on managing symptoms and may include:

• Custom shoe inserts
• Pain-relieving medicines
• Anti-inflammatory treatments
• Steroid injections
• Radiation therapy
• Surgery to remove the nodules in severe cases

Because none of these treatments directly target the underlying condition, there remains a need for new therapeutic options.

About Xiaflex

Xiaflex is currently approved by the US Food and Drug Administration for certain urological and orthopedic conditions.

The latest Phase 3 results suggest the medicine may also become a treatment option for plantar fibromatosis if it receives regulatory approval.

The successful trial expands the potential use of Xiaflex into another disease area where patients currently have very few treatment choices.

About Keenova Therapeutics

Keenova Therapeutics is a US-focused branded therapeutics company that develops treatments for rare diseases and conditions with limited treatment options.

Its portfolio covers multiple specialty areas, including rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.

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