Kuros Biosciences completed enrollment in the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in single-level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease (DDD).
Fibrin-PTH is a novel parathyroid hormone-based healing matrix allowing targeted, controlled bone generation.
The STRUCTURE trial is being conducted under an open Investigational New Drug program for spinal fusion, which was filed with FDA in 2020. STRUCTURE has enrolled 50 patients with DDD requiring single-level interbody fusion with concomitant posterolateral fusion. 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 II study, the Phase III program will be initiated.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “This is a major milestone for the company as well as the patients and surgeons we serve across the globe. We look forward with great anticipation to the initial readout from the Phase II trial, which we estimate will be in December of this year.”
Kuros Biosciences completed enrollment in the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in single-level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease (DDD).
Fibrin-PTH is a novel parathyroid hormone-based healing matrix allowing targeted,...
Kuros Biosciences completed enrollment in the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in single-level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease (DDD).
Fibrin-PTH is a novel parathyroid hormone-based healing matrix allowing targeted, controlled bone generation.
The STRUCTURE trial is being conducted under an open Investigational New Drug program for spinal fusion, which was filed with FDA in 2020. STRUCTURE has enrolled 50 patients with DDD requiring single-level interbody fusion with concomitant posterolateral fusion. 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 II study, the Phase III program will be initiated.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “This is a major milestone for the company as well as the patients and surgeons we serve across the globe. We look forward with great anticipation to the initial readout from the Phase II trial, which we estimate will be in December of this year.”
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