Innovation in bone healing and tissue repair

KUR-111 is a product candidate that has been specifically designed as a bone graft that safely and effectively regenerates bone, without having to resort to a harvesting procedure.

KUR-111 incorporates three key components:

  • -a natural matrix (fibrin) to allow for the natural healing process to proceed, with
  • -a potent, targeted biologic ("PTH") to augment the healing response; and
  • -a structural ceramic component to provide mechanical stability during the healing process.

The combination of these three components provides the key efficacy and safety profile to address the medical need. In addition, KUR-111 is designed as an easy-to-use device, forming a paste that can be easily administered into the various fracture voids as required. The material has also been designed to polymerize in situ to adopt the shape of the defect and to form a perfect space filling graft substitute that resists compression, while providing optimal biological support for the healing process.

KUR-111 has completed a Phase IIb clinical trial assessing its potential for the treatment of patients with tibial plateau fractures that require fixation and grafting. Tibial plateau fractures are fractures of the upper end of the tibia, the major bone of the lower leg. These fracture are often complex and are usually caused by high-energy trauma, such as car or industrial accidents or sports injuries.

The completed Phase IIb 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 (press release, data presented at 2015 Annual Meeting of the Orthopedic Trauma Association in San Diego, USA). This Phase IIb trial was a randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study. The study treated 183 patients at 30 centers across Europe and Australia. At 16 weeks, 84% of autograft treated patients and 84% of patients treated with the higher dose of KUR-111 had radiological fracture healing. Secondary endpoints related to efficacy were consistent with the primary endpoint. For example a composite endpoint of CT scan and clinical healing gave 72% for the higher concentration of KUR-111 and 64% for autograft. There were no indications of any safety issues.

KUR-111 being applied
to a patient's fracture site

Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 (0)44 200 56 00   Fax: +41 (0)44 200 56 01   Email: info@kuros.ch

About Kuros

  1. Overview
  2. Management
  3. Board

Products

  1. Pipeline
  2. Orthobiologics
    Fracture repair
    KUR-111
    KUR-113
    Spinal fusion
    KUR-113
    Solitary Bone Cysts
    KUR-112
  3. Sealants
    Neuroseal (KUR-023)

Technologies

  1. Overview
  2. Fibrin-based
  3. Synthetic-based
  4. Immune modulation
  5. Publications

Partnerships

  1. Collaborations
  2. Business development

Investors

  1. Share price
  2. Regulatory filings
  3. Reports & presentations
  4. Calendar
  5. Corporate governance
  6. Stay informed

News

  1. Press releases
  2. Conferences & Events

Contact

  1. Location
KUR-111

KUR-111 is a product candidate that has been specifically designed as a bone graft that safely and effectively regenerates bone, without having to resort to a harvesting procedure.

KUR-111 being applied
to a patient's fracture site

KUR-111 incorporates three key components:

  • -a natural matrix (fibrin) to allow for the natural healing process to proceed, with
  • -a potent, targeted biologic ("PTH") to augment the healing response; and
  • -a structural ceramic component to provide mechanical stability during the healing process.

The combination of these three components provides the key efficacy and safety profile to address the medical need. In addition, KUR-111 is designed as an easy-to-use device, forming a paste that can be easily administered into the various fracture voids as required. The material has also been designed to polymerize in situ to adopt the shape of the defect and to form a perfect space filling graft substitute that resists compression, while providing optimal biological support for the healing process.

KUR-111 has completed a Phase IIb clinical trial assessing its potential for the treatment of patients with tibial plateau fractures that require fixation and grafting. Tibial plateau fractures are fractures of the upper end of the tibia, the major bone of the lower leg. These fracture are often complex and are usually caused by high-energy trauma, such as car or industrial accidents or sports injuries.

The completed Phase IIb 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 (press release, data presented at 2015 Annual Meeting of the Orthopedic Trauma Association in San Diego, USA). This Phase IIb trial was a randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study. The study treated 183 patients at 30 centers across Europe and Australia. At 16 weeks, 84% of autograft treated patients and 84% of patients treated with the higher dose of KUR-111 had radiological fracture healing. Secondary endpoints related to efficacy were consistent with the primary endpoint. For example a composite endpoint of CT scan and clinical healing gave 72% for the higher concentration of KUR-111 and 64% for autograft. There were no indications of any safety issues.