Keenova Therapeutics has announced positive results from its phase 3 clinical trial of Xiaflex (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic medical condition that causes nodules composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot.
The results:
- The pivotal trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in pain versus placebo, as measured by the average daily pain intensity on the numeric rating scale (NRS).
- It also met key ranked secondary endpoints related to difficulty and activity limitation as measured by the foot function index (FFI) scale.
- The treatment benefit observed on the primary pain endpoint and key functional secondary endpoints was further supported by statistically significant improvements in additional secondary measures, including the FFI pain subscale, global assessments of improvement and disease severity, treatment satisfaction, and nodule characteristics.
- The safety profile of Xiaflex in this study was consistent with the known safety profile of Xiaflex from approved indications. Most adverse events were rated by the investigators as mild to moderate and there were no treatment-related serious adverse events.
Based on claims data and projections, the company believes about 300,000 people will see a healthcare provider for their plantar fibromatosis in 2028, when Keenova expects to launch Xiaflex for the indication.
Xiaflex is currently approved by the US Food and Drug Administration (FDA) for urological and orthopaedic conditions.
