US-based therapeutics company Keenova Therapeutics plc on Wednesday reported positive Phase 3 results for XIAFLEX, its collagenase treatment for plantar fibromatosis, a chronic condition characterised by collagen-based nodules in the foot's connective tissue.

The EN3835-309 Phase 3 trial enrolled 436 participants with plantar fibromatosis and at least one measurable fibrous nodule, randomising them to XIAFLEX or placebo for up to two treatments.

The study met its primary endpoint, showing statistically significant and clinically meaningful pain reduction versus placebo on the Numeric Rating Scale. Secondary endpoints on the Foot Function Index were also achieved, with further improvements recorded across additional measures including FFI pain, global assessments, treatment satisfaction and nodule characteristics.

Safety outcomes were consistent with the established profile of XIAFLEX, with most adverse events rated mild to moderate and no treatment-related serious adverse events.

Plantar fibromatosis is a progressive disorder causing collagen nodules along the plantar fascia, leading to pain and impaired mobility. No approved pharmacological treatments exist, with current options limited to symptom management or surgery.

Keenova expects around 300,000 people to seek care for plantar fibromatosis in 2028, and the company plans to submit an application to the US Food & Drug Administration for this indication in the fourth quarter of 2026. XIAFLEX is already approved in the United States for urological and orthopaedic uses.