A Phase 2 randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study of the safety and efficacy of Fibrin-PTH (KUR-111) in the treatment of patients with fractures of the tibial plateau requiring grafting. KUR-111 is composed of a variant of parathyroid hormone (PTH), fibrin sealant and hydroxyapatite/tri-calcium phosphate (HA/TCP) granules. KUR-111 utilizes Kuros’ “TG-hook” technology for covalently binding PTH into the fibrin sealant. The study included PTH in fibrin at high or low dose and compared to autograft alone.5
Primary & secondary endpoints
Two hundred (183) patients were followed for 16 weeks and assessed for radiological evidence of fracture union. Fracture union was defined as cortical bridging on at least 1 visible plane; endosteal healing (obliteration of the fracture lines) and absence of dislocation of bone fragments compared to the post-op film. Secondary endpoints at 16 and 52 weeks included a clinical assessment, adverse events and secondary interventions.
The study achieved its primary efficacy endpoint, which was the demonstration of statistical non-inferiority to autograft with respect to the proportion of patients who achieved radiological fracture union at 16 weeks after grafting. During the one-year follow-up, there was continuing improvement with radiological fracture union in 96.2% of patients treated with low dose KUR-111, 100% of those treated with high dose KUR-111 and 98.2% of those treated with autograft. Treatment with KUR-111 was well tolerated with few adverse events reported in the long-term follow-up.
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