Keenova doses first patient in Phase 3 XIAFLEX hammer toe trial

Keenova Therapeutics has enrolled and treated the first patient in KN3835-313, a Phase 3 trial evaluating investigational nonsurgical use of XIAFLEX (collagenase clostridium histolyticum) for hammer toe. The double-blind, randomized, placebo-controlled study is expected to include about 550 participants at approximately 35 U.S. sites and is registered as NCT07759362. Its primary endpoint is improvement in the ability to straighten the affected toe by reducing flexion contracture of the proximal interphalangeal joint. Secondary measures include foot function, activity limitations and patients’ assessment of disease severity. No FDA-approved nonsurgical therapy is currently indicated for hammer toe, which is generally managed with footwear changes, orthotics, exercises, pain medication or surgery. XIAFLEX is approved in the U.S. for urological and orthopedic conditions but remains investigational for hammer toe.

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