Innovation in bone healing and tissue repair
A large number of fracture repair surgeries each year are not suitable for the use of a bone graft or bone graft substitutes, and therefore the healing process may be compromised.
Standard treatment of open long bone fractures is to clean (debride) the local soft tissue damage, to reduce and fixate the fracture with inter-medullary nailing or plates, and to close the wound. However, if the fracture is complex and occurs in the middle of the bone, fixating the fracture may not be sufficient to support the healing of the fracture. As a consequence there is significant morbidity and loss of quality of life for the patient during the healing process. There is a clear medical need for this set of patients to improve healing and improve outcomes.
KUR-113 consists of a natural healing matrix (fibrin) which is combined with a targeted bone growth factor (PTH). The product candidate is applied directly into the fracture's gaps and polymerizes in situ to form a gel-like material that infiltrates fracture sites without disturbing the surrounding tissue. KUR-113 is intended to increase the number of patients that completely heal following the initial treatment.
KUR-113 has completed a randomized, controlled, open-label (dose-blinded) dose finding Phase II study of the safety and efficacy of KUR-113 in patients with acute open tibial shaft fractures. A total of 200 patients were randomized and treated in 31centers across Europe. Three doses of KUR-113 in combination with standard of care (SOC) were compared with SOC alone. The healing rates were 63% in the SOC alone group versus 74%, 83%, and 75% for the 0.133, 0.4 and 1.0 mg/ml KUR-113 groups respectively (press release).
KUR-113 being applied to two sites of a fractured tibia
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