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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
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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