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Fibrin-PTH: In pursuit of the first drug-biologic combination for spinal fusion
Welcome to the latest candidate in our pipeline
Fibrin-PTH (KUR-113) is the latest candidate in our pipeline – and the first ever investigational drug-biologic candidate to be evaluated for spinal fusion.
It’s based on proprietary controlled-release technology that combines the well-established mechanism of the bone growth factor parathyroid hormone (PTH) with the natural healing matrix, known as fibrin.* Once implanted, Fibrin-PTH promotes spinal fusion by increasing the number and lifespan of bone-forming (osteogenic) cells in the fusion space.
Fibrin-PTH is also the first investigational drug-biologic to be compatible with narrow gauge cannulas for truly non-invasive surgical procedures – with the potential to be a true game changer once commercially available.
Current clinical trials
Fibrin-PTH is now undergoing a Phase 2 clinical trial for spinal fusion in the United States as part of a de-risked pre-market clinical program.
Clinical evidence
Fibrin-PTH has featured in two separate Phase 2 randomized, controlled, open-label, dose-blinded studies – featuring 383 total patients.1,2
Tibial plateau fractures: the statistical non-inferiority of Fibrin-PTH to autograft was demonstrated based on the proportion of patients who achieved radiological fracture union at 16 weeks, post-graft. Thus, the study achieved its primary efficacy endpoint.
Tibial shaft fractures: the healing rate at six months post-surgery for intend-to-treat patients was 76%, 80% & 69% for patients receiving the low, medium & high doses of Fibrin-PTH respectively – versus just 65% for those receiving Standard of Care.
Suggested Reading
References And Disclaimers
1. Data on file, 2011; Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF), ClinicalTrials.gov Identifier: NCT00533793.
2. Data on file, 2011; Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting, ClinicalTrials.gov Identifier: NCT00409799.
*Fibrin-PTH (KUR-113) is an investigational drug-biologic combination product candidate. Fibrin-PTH (KUR-113) has been evaluated in animals for use in lumbar interbody fusion. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.
PROMO/KUR/GL/062-21/R02