Date: 2011-04-26
Type of information:
phase: 2b
Announcement: results
Company: Kuros Biosurgery (Switzerland)
Product: KUR-113
Action mechanism: KUR-113 consists of fibrin matrix and a variant PTH (Parathyroïd hormone). The aim of KUR-113 is to promote bone formation and accelerate fracture repair. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth.
Disease: open tibial shaft fracture
Therapeutic area:
Country: Europe
Trial details: The Phase IIb study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. A total of 200 patients were randomized and treated in 31 centers across Europe. Three doses of KUR-113 in combination with SOC were compared with SOC alone.
Latest
news: Kuros Biosurgery AG has announced that KUR-113 (Viz.I-040202) met the primary efficacy endpoint in a 200 patient Phase IIb clinical trial designed to assess its efficacy and safety in open tibial shaft fracture patients. The primary endpoint of the study is the proportion of patients healed at 6 months after surgery, comparing KUR-113 in combination with standard of care (SOC) to SOC alone. The use of KUR-113 is designed to improve fracture union and thus reduce the time needed to achieve bone healing as well as the incidence of secondary interventions.
In the Intent-to-Treat (ITT) population the healing rate at 6 months after surgery, as assessed by the investigators using radiographic and clinical criteria, was 65% for patients treated with SOC alone versus 76%, 80%, and 69% for the 0.133, 0.4 and 1.0 mg/ml KUR-113 groups respectively. In the Per-Protocol (PP) population, 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. For both analyses the 0.4 mg/ml group had significantly better healing than SOC alone group. To date there are no indications of any safety issues. Analysis of the secondary endpoints is ongoing.
