This article is more than 5 years old. Information may no longer be current.
Kuros meets primary endpoint in Phase IIb trial of KUR-113 in patients with open tibial shaft fractures
Click Here to Manage Email Alerts
Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, 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, according to a company press release, is the proportion of patients healed six months postoperatively, comparing KUR-113 in combination with standard of care (SOC) to SOC alone. The use of KUR-113 is reportedly designed to improve fracture union and thus reduce the time needed to achieve bone healing, as well as the incidence of secondary interventions. The Phase IIb study is a randomized, controlled, open-label dose-finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures.
“We are extremely pleased to have met the primary endpoint of this study,” Virginia Jamieson, MD, chief medical officer of Kuros, stated in the release. “Demonstrating a significant improvement in the clinically assessed healing rate in patients with open tibial shaft fractures, using a very challenging endpoint, is a great achievement for a Phase II trial with this number of patients”.
According to the press release, KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. 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 reportedly also plays an important role in the bone healing process by providing a physical scaffold for cell ingrowth.