Kuros Biosurgery AG, a biotechnology company developing novel biomaterials and bioactive-biomaterial combination products, has announced that positive preclinical data assessing the potential of KUR-115 as a lumber interbody spinal fusion treatment will be presented at the 2015 North American Spine Society (NASS) event in Chicago (Illinois, USA) by Dr Bryan W. Cunningham. Dr Cunningham was lead investigator of the study, which was done at the Orthopaedic Spinal Research Institute, University of Maryland.
The objective of the study was to evaluate and compare the efficacy of KUR-115 in various concentrations versus autograft and bone morphogenetic protein-2 (BMP-2) controls for lumbar interbody spinal arthrodesis.
The study achieved its primary objective, which was the demonstration of a fusion identified at 4 and 10 months in 8/8 levels treated with the optimal concentration of KUR-115 (0.4 mg/mL) as well as the autograft and BMP-2 controls — all following a direct lateral surgical approach, complete diskectomy and endplate decortication at L2-L3 and L4-L5.
Flexion-extension and lateral bending exhibited reduced segmental motion for all treatment groups at 4 months versus the non-operative intact spine (p<0.05). By 12 months, both axial rotation and flexion-extension motion were significantly lower than the intact spine (p<0.05). Histopathology indicated no evidence of foreign body/inflammatory reaction or significant pathological changes in any specimens.
There were also no significant intra-or peri-operative complications in any cases.
Dr Bryan W. Cunningham commented: “These positive preclinical results suggest that KUR-115 could be a highly effective alternative to autograft in lumbar interbody spinal arthrodesis. This study will serve as a basic scientific basis for future clinical investigations into the use and efficacy of parathyroid hormone based approaches for the treatment of a number of spinal indications.”
Didier Cowling, Chief Executive Officer, said: “These positive results further highlight the significant potential of Kuros’ technology platform in a broad range of spinal and orthopaedic indications. We look forward to progressing KUR-115 into clinical development and adding to the positive data generated in large Phase IIb studies by KUR-111 and KUR-113.”
The preclinical study was performed on 32 skeletally mature sheep and randomized into post-operative time periods of 4 months (n=20) and 10 months (n=12). Treatment was administered using rectangular PEEK cages (sample size of n=8) prefilled with the following treatments per time period: 4 month treatments – KUR-115 at 0.2 mg/mL, 0.4 mg/mL and 0.7 mg/mL in a fibrin matrix, autograft and bone morphogenetic protein-2 (BMP-2). 10 Month Treatments – KUR-115 at 0.4 mg/mL in fibrin, autograft and BMP-2.