Phase IIB study with KUR-111 meets primary efficacy endpoint
Kuros Biosurgery AG, a biotechnology company developing novel biomaterials and bioactive-biomaterial combination products, today announces that positive results of a Phase IIb trial assessing the potential of KUR-111 in the treatment of patients with tibial plateau fractures that require fixation and grafting will be presented at the 2015 Orthopaedic Trauma Association Annual Meeting in San Diego, California, by Dr. Tom Lyon, Director of Orthopaedics and Chief of Orthopaedic Trauma, NYU Lutheran Medical Center, on 9thOctober 2015 at 8:30a.m. PDT.
KUR-111 is designed to be a next generation orthobiologic with a number of potential clinical applications. It combines market leading efficacy with excellent safety and ease of use.
The Phase IIb trial was a randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study in which 183 patients with fractures of the Tibial Plateau were treated with either iliac crest cancellous autograft, or high concentration or low concentration KUR-111.
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. At 16 weeks post-surgery, 84% of autograft treated patients and 84% of patients (Intent to treat populations) treated with the higher dose of KUR-111 had radiological fracture healing defined by an independent radiology panel using CT Scans.
Additional secondary endpoints included measuring radiographic healing, clinical healing and maintenance of reduction at the 16 week timepoint but also at earlier (6 and 12 weeks) and later (6, 12 and 24 months) timepoints. In the composite endpoint at 16 weeks, which combined CT and clinical outcomes, 72% of the patients treated with the high concentration of KUR-111 healed compared to 63% of those treated with autograft (Intent to treat populations). Maintenance of reduction was also demonstrated with minimal loss observed at all time points, out to the end of the study at 24 months. There were also no indications of any safety issues.
Dr. Tom Lyon, Director of Orthopaedics and Chief of Orthopaedic Trauma, NYU Lutheran Medical Center, commented: "These exciting results show that KUR-111 could be a highly effective alternative to autograft, or to other bone graft substitutes. The positive efficacy data combined with the clean safety profile and ease of use suggests that KUR-111 is well placed to become a strong addition to the surgeons' arsenal of bone graft substitutes."
Didier Cowling, Chief Executive Officer, said: "These positive results further highlight the significant potential of Kuros' technology platform and our novel clinical-stage orthobiologics pipeline. We look forward to continuing the clinical development of KUR-111, a product that we believe can deliver clear benefits to surgeons, patients and payors. "
KUR-111 is composed of a variant of parathyroid hormone (vPTH), fibrin sealant and
hydroxyapatite/tri-calcium phosphate (HA/TCP) granules. The product has been developed to combine a high level of efficacy with ease of use and safety. It is applied directly to the fracture site as a mouldable putty able to form to the shape of the bone defect.
Kuros is focused on the development of novel biomaterials and bioactive-biomaterial combination products in therapeutic areas covering sealants and orthobiologics.
Kuros has a late stage pipeline which has generated highly encouraging data in multiple clinical studies. Its most advanced sealant product candidate is KUR-023, a sealant that has successfully completed European clinical development and is close to being CE Marked. KUR-111 and KUR-113, Kuros' most advanced orthobiologic products have both met the primary endpoints in large well controlled Phase II clinical studies and are progressing towards Phase III.
Kuros has two biomaterial technology platforms, one based on fibrin sealants and the other based on its own proprietary synthetic technology that can mimic fibrin in many of its attributes. These materials can be used alone or in combination with biologically active molecules, and can be delivered in many forms including as injectable liquids, sprays, gels, pastes or preformed implants. The incorporation of the biologically active molecules into the matrices aims to maximize their activity by retention at the site of action. Kuros has a number of methodologies to achieve the desired retention and release profiles of the biologically active molecules. The products are designed to combine ease of application with localized delivery.