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Fibrin-PTH

Our latest product candidate delivers targeted and controlled bone formation.

Fibrin-PTH (KUR-113) promotes bone formation through the induction of osteoprogenitor cell differentiation, enhancement of osteoblast proliferation and by increasing the lifespan of bone-forming cells. Fibrin-PTH (KUR-113) has entered a Phase 2 clinical trial for spine fusion in humans.

Fibrin-PTH (KUR-113) is the first ever investigational drug-biologic product candidate being evaluated for spinal fusion.#

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Fibrin-PTH
(KUR-113)

This product candidate is based on the well-established mechanism of action of parathyroid hormone – or PTH as it is commonly known – and the natural healing matrix fibrin. Using its proprietary technology, a modified PTH is covalently bound to fibrin through the TG-Hook peptide linker, which also contains a site for enzyme-mediated release of PTH.1

Watch to find out how Fibrin-PTH (KUR-113) can achieve spinal fusion through prolonged and controlled delivery of PTH from a single application in the spine.

Comparable efficacy to rhBMP-2

Demonstrated for Fibrin-PTH (KUR-113) in preclinical animal studies of spinal fusion.2*#

Easy to use

Excellent flowability and setting properties for Fibrin-PTH (KUR-113) in preclinical studies.3*#

Clinical experience

Effective for bone healing with a promising safety profile in two Phase 2 orthopedic trauma trials.4,5

Currently in a Phase 2 Clinical Trial

Fibrin-PTH (KUR-113) has entered Phase 2 clinical trials for spine fusion in humans.6

Tibial plateau fractures

Study design

A Phase 2 randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study of the safety and efficacy of Fibrin-PTH (KUR-111) in the treatment of patients with fractures of the tibial plateau requiring grafting. KUR-111 is composed of a variant of parathyroid hormone (PTH), fibrin sealant and hydroxyapatite/tri-calcium phosphate (HA/TCP) granules. KUR-111 utilizes Kuros’ “TG-hook” technology for covalently binding PTH into the fibrin sealant. The study included PTH in fibrin at high or low dose and compared to autograft alone.5

Primary & secondary endpoints

Two hundred (183) patients were followed for 16 weeks and assessed for radiological evidence of fracture union. Fracture union was defined as cortical bridging on at least 1 visible plane; endosteal healing (obliteration of the fracture lines) and absence of dislocation of bone fragments compared to the post-op film. Secondary endpoints at 16 and 52 weeks included a clinical assessment, adverse events and secondary interventions.

Key outcomes

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. During the one-year follow-up, there was continuing improvement with radiological fracture union in 96.2% of patients treated with low dose KUR-111, 100% of those treated with high dose KUR-111 and 98.2% of those treated with autograft. Treatment with KUR-111 was well tolerated with few adverse events reported in the long-term follow-up.

Tibial shaft fractures

Study design

A Phase 2 randomized, controlled, open-labeled (dose-blinded) dose finding study of the safety and efficacy of Fibrin-PTH (KUR-113) in the treatment of patients with acute open tibial shaft fractures. KUR-113 is composed of a variant of parathyroid hormone (PTH) and fibrin sealant. KUR-113 utilizes Kuros’ “TG-hook” technology for covalently binding PTH into the fibrin sealant. The study included PTH in fibrin at high, medium or low dose as an adjunct to standard of care (mechanical fixation) compared to standard of care alone.4

Primary & secondary endpoints

Two hundred (200) patients were followed for 6 months and assessed for radiological evidence of fracture union. Fracture union was defined as cortical bridging on at least 1 visible plane; healing (obliteration of the fracture lines) and absence of signs for complications such as infection and malunion. Secondary endpoints at up to 52 weeks included a clinical assessment, adverse events and secondary interventions.

Key outcomes

The healing rate at 6 months after surgery for the intend-to-treat population, as assessed by the investigators using radiographic and clinical criteria, was 65% for patients treated with standard of care (SOC) alone versus 76%, 80%, and 69% for the low, medium, and high doses of PTH in fibrin, respectively. In the per-protocol population, the healing rates were 63% in the SOC alone group versus 74%, 83%, and 75% for the low, medium, and high dose groups, respectively. For both analyses, the medium dose group had significantly better healing than the SOC alone group. There were no indications of safety issues in this investigational study.

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