Keenova Therapeutics reported positive phase 3 results for Xiaflex in patients with plantar fibromatosis, potentially positioning the injectable biologic enzyme for a third approved indication.
The trial enrolled 436 patients and met its primary endpoint. According to the company, the study showed “statistically significant and clinically meaningful reductions in pain versus placebo” when measured using the Average Daily Pain Intensity Numeric Rating Scale (NRS). Patients recorded foot pain on a scale from 0 to 10, with a two-point difference considered clinically meaningful. Keenova did not disclose the specific scores from the study.
Participants received two injections of Xiaflex separated by at least 28 days. The trial also achieved its secondary endpoints, which were assessed using the Foot Function Index (FFI). The 23-item questionnaire measures pain, disability, and activity limitation, with responses recorded on a 0-to-10 scale. The company reported that the study met both its primary and secondary measures of effectiveness.
Keenova reported that the safety profile observed in the study was consistent with the established safety profile of Xiaflex in its currently approved indications. Most adverse events were classified by investigators as mild to moderate. The company stated that no treatment-related serious adverse events occurred during the trial. The reported safety findings were in line with those previously seen for the product in its approved uses.
Marek Honczarenko, M.D., chief scientific officer of Keenova, said the company plans to submit an application for FDA approval in the fourth quarter of this year and hopes to launch Xiaflex for plantar fibromatosis in 2028.
Plantar fibromatosis, also known as Ledderhose disease, is characterized by the formation of lumps composed primarily of excess collagen in the connective tissue that supports the arch of the foot. The condition can cause pain, swelling, and difficulty walking. Based on claims data and projections, Keenova estimates that 300,000 people will visit a healthcare provider for plantar fibromatosis in 2028. The disease affects tissue in the arch of the foot, where the collagen-rich growths can develop over time.
There is currently no medicine specifically approved for plantar fibromatosis. Patients may receive radiation therapy or corticosteroid injections for symptom relief, while surgery is generally reserved as a last option. As a result, available treatment approaches are currently limited to these management options.
Xiaflex works by breaking down collagen. In its approved uses, the treatment is used to dissolve and soften thickened cords associated with Dupuytren’s contracture and Peyronie’s disease. The FDA approved Xiaflex for Dupuytren’s contracture in 2010 and for Peyronie’s disease in 2013. Those two conditions remain the currently approved indications for the therapy.
The treatment was originally developed by Auxilium Pharmaceuticals, a Pennsylvania-based biotechnology company that was acquired by Endo in 2014 for $2.6 billion. Last year, Endo and Mallinckrodt merged in a $6.7 billion transaction. Eight months ago, the companies spun off their generics business as Par Health and rebranded as Keenova.
Xiaflex generated sales of $546 million last year and $134 million during the first quarter of 2026, representing an 11% year-over-year increase. Keenova reported first-quarter 2026 revenue of $468 million, including $170 million from Acthar Gel, a treatment for inflammatory and autoimmune conditions whose sales have recently increased following the introduction of a new self-injection delivery device.
Xiaflex has successfully met the primary endpoints in a Phase 3 clinical study evaluating its use in patients with plantar fibromatosis. The positive results represent an important milestone for Xiaflex, demonstrating its potential as a minimally invasive treatment for a condition that often causes painful nodules in the foot. If approved for this indication, Xiaflex could provide patients with an alternative to surgery and other more invasive treatment options.
Understanding Plantar Fibromatosis
Plantar fibromatosis, also known as Ledderhose disease, is a rare condition characterized by the formation of fibrous nodules in the plantar fascia of the foot. These nodules can become painful and interfere with walking and daily activities. The Phase 3 study evaluated whether Xiaflex could safely reduce the size of these nodules and improve patient symptoms without requiring surgical intervention.
Potential Benefits of Xiaflex Treatment
The successful Phase 3 results suggest that Xiaflex may offer several advantages for patients with plantar fibromatosis. As an injectable treatment, Xiaflex could reduce the need for surgery, shorten recovery times, and minimize complications associated with more invasive procedures. A non-surgical treatment option may also improve quality of life for patients experiencing pain and mobility limitations
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