Keenova Initiates Phase 3 Trial for Hammer Toe Treatment
Keenova has begun a Phase 3 clinical trial in the US and Europe for XIAFLEX® to treat hammer toe, with the first patient now dosed. No non-surgical treatments are currently approved for hammer toe.
Pharmaceutical company Keenova has initiated a Phase 3 clinical trial in the United States and Europe evaluating XIAFLEX® (collagenase clostridium histolyticum) for the treatment of hammer toe. The company announced today that the first patient has been dosed in the study, which aims to assess the drug's efficacy, safety, and tolerability in adult patients with hammer toe.
Hammer toe is a common foot deformity, and current treatment options are largely limited to orthotics and surgical procedures. The U.S. Food and Drug Administration (FDA) has not approved any non-surgical therapies specifically indicated for hammer toe, highlighting a need for new treatment modalities.
This marks the first registered, randomized Phase 3 trial for XIAFLEX® in this indication. The study is expected to provide key data on the drug's potential as an alternative to surgical correction. Keenova aims to offer patients a less invasive treatment option that could improve quality of life and reduce recovery time compared to traditional surgery.
The company anticipates that the trial results will help establish XIAFLEX® as a viable treatment for hammer toe. Findings are expected at a later date.