First Patient Treated in Kuros Study of Fibrin-PTH for DDD

Kuros Biosciences A.G., the Swiss maker of MagnetOS synthetic bone graft is currently testing its first drug-biologic bone graft, Fibrin-PTH (KUR-113). The drug-biologic is intended for spinal fusion in cases of degenerative disc disease (DDD) and is subject to the U.S. FDA’s Investigational New Drug (IND) application pathway.

Fibrin-PTH is a flowable drug-biologic bone graft composed of a truncated form of human parathyroid hormone immobilized on a fibrin-based matrix. Preclinical testing has shown fusion rates comparable to rhBMP-2. It is delivered through a needle into and around a PEEK interbody cage used in a transforaminal lumbar interbody fusion (TLIF) procedure.

The STRUCTURE trial is a phase 2 study being conducted in the U.S. at the University of California San Diego in San Diego (UCSD) and the Spine Institute of Louisiana in Shreveport, Louisiana. The study will enroll 50 patients between the two sites and compare the drug-biologic to autograft in similar procedures. Stage 1 of the study will provide patients receiving the experimental therapy a dose of 0.4mg/ml (up to 4mg), while stage 2 will involve either a higher or lower dosage based on results from stage 1.

The first patient has been treated at the UCSD site by Richard Todd Allen, M.D., Ph.D., an Associate Professor of Orthopaedic Surgery at UC San Diego Health. Allen commented on the milestone by saying, “I am very pleased to be part of this unique study and to have enrolled the first patient. Given the strong pre-clinical data and ease of application of Fibrin-PTH, being particularly suitable for minimally invasive surgeries, I see great potential for this novel drug-biologic combination product.”

The company is hopeful that with the resumption of elective surgeries in much of the U.S., further delays to the study will be non-existent. Kuros Chief Executive Officer Joost de Bruijin stated in a company press release:“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.”

Prior versions of the drug-biologic were tested for tibial plateau and tibial shaft fractures. The drugs were originally developed in conjunction with Baxter International, Inc., but Kuros regained full rights to KUR-113 in 2011.