Kuros Biosciences completed enrollment in the randomized stage of the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in transforaminal lumbar interbody fusion procedures in patients with degenerative disc disease (DDD).
No drug-related SAEs were reported in the first stage of the Phase II randomized, dose-finding, multicenter study. The STRUCTURE trial is being conducted under an open Investigational New Drug program for spinal fusion, which was filed with FDA in 2020. STRUCTURE will enroll 50 patients with DDD requiring single-level interbody fusion with concomitant posterolateral fusion.
In the first stage of the trial, 30 patients were randomized into two arms, the first receiving Fibrin-PTH and the second receiving local autograft, which serves as control. Fibrin-PTH or local autograft were applied in and around FDA-cleared PEEK cages, respectively. Enrollment is underway for the remaining 20 patients for the second, non-randomized part of the trial, in which all subjects will receive Fibrin-PTH at a higher concentration. The primary endpoint of the trial is radiographic interbody fusion using CT scans at 12 months, as determined by an independent radiology expert panel.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “We are pressing ahead with the next stage of this trial and are looking forward to full enrollment of the study and primary endpoint read out of the randomized part of the study due next year.”
Kuros Biosciences completed enrollment in the randomized stage of the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in transforaminal lumbar interbody fusion procedures in patients with degenerative disc disease (DDD).
No drug-related SAEs were reported in the first stage of the Phase II randomized,...
Kuros Biosciences completed enrollment in the randomized stage of the STRUCTURE trial, which is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in transforaminal lumbar interbody fusion procedures in patients with degenerative disc disease (DDD).
No drug-related SAEs were reported in the first stage of the Phase II randomized, dose-finding, multicenter study. The STRUCTURE trial is being conducted under an open Investigational New Drug program for spinal fusion, which was filed with FDA in 2020. STRUCTURE will enroll 50 patients with DDD requiring single-level interbody fusion with concomitant posterolateral fusion.
In the first stage of the trial, 30 patients were randomized into two arms, the first receiving Fibrin-PTH and the second receiving local autograft, which serves as control. Fibrin-PTH or local autograft were applied in and around FDA-cleared PEEK cages, respectively. Enrollment is underway for the remaining 20 patients for the second, non-randomized part of the trial, in which all subjects will receive Fibrin-PTH at a higher concentration. The primary endpoint of the trial is radiographic interbody fusion using CT scans at 12 months, as determined by an independent radiology expert panel.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “We are pressing ahead with the next stage of this trial and are looking forward to full enrollment of the study and primary endpoint read out of the randomized part of the study due next year.”
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