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

Kuros Biosciences AG / Key word(s): Study results Kuros Biosciences Announces Completion of Enrollment in the Fibrin-PTH Phase 2 Trial 13.07.2023 / 19:29 CET/CEST First investigational trial of drug-biologic bone graft for spinal fusion 50 patients have been enrolled in the Phase 2 trial Potential to address $2.2B market opportunity Schlieren (Zurich), Switzerland, July 13, 2023 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today the completion of 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. “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.”