The double-blind, randomized study, registered as KN3835-313, aims to recruit approximately 550 participants across 35 sites in the United States. Researchers are testing whether the injectable drug can effectively reduce flexion contracture of the proximal interphalangeal joint, the primary driver behind the characteristic downward bend of the toe. Success in this trial would fill a significant gap in the orthopedic market, as no nonsurgical therapy for the condition has yet earned FDA approval.
Keenova Launches Phase 3 Trial for Nonsurgical Hammer Toe Treatment
Keenova Therapeutics has enrolled the first patient in a pivotal Phase 3 clinical trial for XIAFLEX, marking a potential shift in how clinicians manage hammer toe. Currently, patients suffering from the painful foot deformity face limited options, relying largely on orthotics, physical therapy, or invasive surgical correction to restore mobility.
Dr. Marek Honczarenko, Keenova’s Chief Scientific Officer, noted that the treatment seeks to address a condition that often severely impairs daily function and quality of life. While XIAFLEX is already authorized for other urological and orthopedic uses, its application for hammer toe remains strictly investigational. The trial will evaluate both the efficacy and safety profile of the drug, tracking changes in foot function and overall severity as reported by patients.
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