Kuros Biosciences Treats First Patient in Spinal Fusion Trial with Fibrin-PTH

Kuros Biosciences announced treatment of the first patient in the STRUCTURE trial investigating Fibrin-PTH (KUR-113) for transforaminal lumbar interbody fusion (TLIF) in patients with degenerative disc disease.

STRUCTURE is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study with the primary endpoint of radiographic interbody fusion, using CT-scans, at 12 months.

The STRUCTURE trial is conducted under an open Investigational New Drug for spinal fusion. The Phase II U.S. trial will enroll 50 patients with degenerative disc disease requiring single-level interbody fusion with concomitant posterolateral fusion. Patients treated with local autograft will serve as controls. KUR-113 or local autograft will be applied in and around PEEK cages.

This represents the first time a drug/biologic bone graft is being tested for the treatment of degenerative disc disease in patients within a clinical trial, and also the first time such a technology is being evaluated for both open and minimally invasive surgical techniques under clinical trial conditions.

Joost de Bruijn, Chief Executive Officer of Kuros, said, “The treatment of the first patient in the STRUCTURE trial is an important milestone for Kuros`s Fibrin-PTH program. Fibrin-PTH targets a substantial clinical need and, if successful, addresses a huge commercial opportunity. We are happy that elective surgeries have resumed in the U.S., and expect recruiting the patients into the study without further delays.”