Kuros Biosciences publishes first-in-human clinical data for Fibrin-PTH (KUR-113) in treatment of open tibial shaft fractures

• Phase II data published in peer-reviewed Journal of Bone and Joint Surgery 
• Healing rate at six months post-surgery was higher than standard of care
• Significantly de-risks development of Fibrin-PTH for spinal fusion

Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today the publication of first-in-human data from a Phase II trial of Fibrin-PTH (KUR-113) in open tibial shaft fractures in The Journal of Bone and Joint Surgery (JBJS), the leading peer-reviewed orthopedic research journal.

The article, entitled “Novel Parathyroid Hormone-Based Bone Graft, KUR-113, in Treatment of Acute Open Tibial Shaft Fracture”, outlined results from the multicenter, randomized, controlled dose-finding study with 200 patients who had an open tibial shaft fracture secondary to trauma. The healing rate at six months post-surgery for intend-to-treat patients was 76%, 80% and 69% for patients receiving the low, medium and high doses of Fibrin-PTH administered on top of standard of care respectively. This compared with 65% for those receiving standard of care alone. The primary endpoint was met in the mid-dose group, with a significantly higher prevalence of healing at six months than the control group. 

Joost de Bruijn, Chief Executive Officer of Kuros, said: "We are proud that the highly respected JBJS journal has published these exciting Phase II results with our bone graft, Fibrin-PTH. The data show that Fibrin-PTH delivers superior healing after six months and suggest our product candidate has the potential to significantly improve treatment options for tibial shaft fractures. This large clinical study in non-spine orthopedic indications significantly de-risks our clinical development program in spine, which represents a significant commercial opportunity. We are continuing to enroll patients in our STRUCTURE Phase II study of Fibrin-PTH in spinal fusion and have already included more than 50% of the patients for the first stage.”

By 12 months, healing had occurred in the majority of subjects in all treatment groups, with the control group requiring more surgical interventions to achieve fracture healing. Adverse events occurred at similar frequencies between the Fibrin-PTH and standard of care groups and no ectopic bone formation or abnormal bone resorption at the fracture site was observed in any of the treatment groups. There were no specific safety concerns for the use of Fibrin-PTH in this patient population.

The annual number of tibial shaft fractures in the United States is estimate at 492,000 union or malunion. Approximately 25% of these are open fractures, which generally result from high-energy trauma and tend to be associated with multiple injuries. Treatment of an open tibial shaft fracture is complex and many cases are associated with delayed bone union or malunion. If healing is delayed, a secondary intervention may be required to promote fracture healing, which leads to higher morbidity, reduced quality of life, and increased cost to the health-care system.

About Fibrin-PTH (KUR-113)
The latest candidate in our pipeline is 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, fibrin. Once implanted, the released PTH promotes spinal fusion by increasing the number and lifespan of bone-forming (osteogenic) cells in the fusion space. Fibrin-PTH is the first ever investigational drug-biologic candidate to be evaluated for spinal fusion; and the first to be compatible with narrow gauge cannulas for truly non-invasive surgical procedures. Fibrin-PTH is undergoing a Phase 2 clinical trial in the US as part of a de-risked pre-market clinical program.

Investigational Product Candidates
Fibrin PTH (KUR-113) is an investigational drug/biologic combination product candidate and is not approved by FDA for the indications mentioned in this release. The safety & efficacy of Fibrin PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.

Forward Looking Statements
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