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

Fibrin-PTH is a novel parathyroid hormone-based healing matrix allowing targeted, controlled bone generation. “This first-of-its-kind, drug-biologic combination product has the potential to transform the way spinal fusions are performed” agreed Dr R. Todd Allen from UCSD, one of the investigators of the study. Due to its injectable formulation, it is particularly well suited for minimally invasive approaches.

Fibrin-PTH targets a substantial clinical need and, upon approval, will address the large musculoskeletal growth factor market projected to reach $2.2B by 2030.

The coordinating investigator of the STRUCTURE study, Dr John Chi from Brigham and Women’s Hospital, commented: “Fibrin PTH is a keystone technology for promoting bone health and I’m excited to see it being used for spinal fusion, which is one of the hardest areas to fuse. I’m so pleased to see this product progressing through clinical development and we are now one step closer to treating many patients.”

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 2 trial, which we estimate will be in December of this year.”

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.