First Ever Drug/Bio Combo IND Approved by FDA for Lumbar Fusion
Courtesy of Kuros Biosciences
The FDA just approved the first ever Investigational New Drug (IND) application to evaluate a drug/biologic combination product for lumbar interbody fusion of the spine.
On September 3, 2019, Swiss-based Kuros Biosciences AG, announced the FDA approval its IND application to initiate a Phase 2a clinical trial to "evaluate the use of Fibrin-PTH (KUR-113) in single level transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease, with autograft (patient’s own bone) as comparator."
Drug/Biologic Combo
Fibrin, according to the company, is formed "by the conversion of a soluble precursor (fibrinogen) to a solid degradable matrix." Commercially, fibrin sealants (without biologics) have been used for more than 30 years, primarily for the prevention of blood loss during surgical procedures.
The company says Fibrin-PTH consists of a "natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog).”
Kuros has a proprietary technology called TG-Hook Technology, which enables covalent linking of biologics into the fibrin matrix.
"A transglutaminase (TG) enzyme called Factor XIIIa is responsible for cross-linking fibrin molecules, thereby forming a solid matrix, whose normal function is to stop blood loss. Kuros’ products employ this same mechanism to cross-link biologics into fibrin during the formation of the fibrin polymer. The TG-Hook Technology is further designed to release the biologic upon cellular infiltration into the matrix," according to the company.
Comparable to rhBMP-2
The product is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. The company adds that the product "functions via the well-established mechanism of action of parathyroid hormone; has been demonstrated in animal models of spinal fusion to be comparable to rhBMP-2; and has been shown in preclinical studies to be easy to use and ideal for open or minimally invasive techniques."
The planned study is a prospective, randomized, controlled, open-label, multi-center, parallel group study with the primary endpoint of radiographic interbody fusion, using CT-scans at 12 months, determined by an independent radiology expert panel.
“Huge Commercial Opportunity”
Company CEO Joost de Bruijn, Ph.D. said if the study is successful, a "huge commercial opportunity” will be opened.
Kuros Biosciences is a spin-off of the Eidgenössische Technische Hochschule Zürich (ETHZ). The company partnered with the University of Zürich and the California Institute of Technology to develop the proprietary TG-Hook Technology. In early 2017 Kuros acquired Xpand Biotechnology, adding the MagnetOs family of bone grafts to the company's portfolio.
