Keenova Reports Positive Phase 3 Results for Plantar Fibromatosis Drug

The pivotal trial, which enrolled 436 participants, met its primary endpoint by showing a statistically significant reduction in daily pain intensity. Beyond pain relief, the study hit key secondary benchmarks, including improvements in activity limitations and overall foot function, as measured by the Foot Function Index. Most adverse events recorded during the study were mild to moderate, aligning with the established safety profile of the drug in its existing orthopedic and urological applications.

Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova, noted that the company plans to submit the data to the FDA in the fourth quarter of 2026. If approved, the treatment would address a chronic, progressive condition that currently lacks any sanctioned pharmacological therapies, often leaving patients reliant on custom orthotics or surgery. Based on current projections, the company anticipates a market launch in 2028, targeting an estimated 300,000 patients who seek professional care for the condition annually.