Kuros Biosciences Announces Completion of Enrollment in the Fibrin-PTH Phase 2 Trial - Seite 2

The STRUCTURE trial is being conducted under an open Investigational New Drug (IND) program for spinal fusion, which was filed with the U.S. Food and Drug Administration (FDA) in 2020. STRUCTURE has enrolled 50 patients with DDD requiring single-level interbody fusion with concomitant posterolateral fusion (PLF). The primary endpoint of the trial is radiographic interbody fusion using CT scans at 12 months, as determined by an independent radiology expert panel. Upon successful completion of the Phase 2 study, the Phase 3 program will be initiated. 

For further information, please contact:

Kuros Biosciences AG  Daniel Geiger Chief Financial Officer Tel [phone] [e-mail]

LifeSci Advisors  Mary-Ann Chang Investors [phone] [e-mail]

About Fibrin-PTH (KUR-113)
Fibrin-PTH (KUR-113) consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog. Fibrin-PTH (KUR-113) is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. Fibrin-PTH (KUR-113) functions via the well established mechanism of action of parathyroid hormone; has been demonstrated in animal models of spinal fusion to be comparable to rhBMP-2; and has been shown in preclinical studies to be easy to use and ideal for open or minimally invasive techniques¹*. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.
 
About Spinal Fusion
Lumbar fusion surgery is designed to create solid bone between adjoining vertebrae of the spine, eliminating any movement between the bones. Spinal fusion may be recommended for conditions such as spondylolisthesis, degenerative disc disease or recurrent disc herniations. The goal of fusion surgery is to reduce pain and nerve irritation. Surgeons perform lumbar fusion using several techniques. One such technique – Transforaminal Lumbar Interbody Fusion (TLIF) – is used to stabilize the spinal vertebrae. This definition is adapted from www.spine-health.com. It is estimated that the orthobiology market for spinal fusion is growing to $2.2 billion in 2030, while currently over 800,000 spinal fusion procedures are performed annually in the U.S. & EU.