Bone Biologics has announced that it has completed a preclinical study, which shows that its rhNELL-1 growth factor effectively promotes bone formation in a phylogenetically advanced spine model. In addition, rhNELL-1 was shown to be well tolerated and there were no findings of inflammation, the company said in a press release.
“The results of this Pivotal animal study provide a promising view of the potential of rhNELL-1 and we look forward to advancing the NELL spine program into clinical trials,” said Jeff Frelick, chief executive officer of Bone Biologics.
“In its second clinically relevant sheep study, rhNELL-1 demonstrated increases in fusion and quantity of bone compared to the control,” said Bill Walsh, professor and director, Surgical and Orthopedic Research Laboratories (SORL), UNSW Sydney.
Bone Biologics previously announced that it received Human Research Ethics Committee (HREC) approval for the first centre of a multicentre pilot clinical trial to evaluate NB1 (NELL-1/DBX) in 30 patients in Australia. The pilot study will evaluate the safety and effectiveness of NB1 in adult subjects with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level who undergo transforaminal lumbar interbody fusion (TLIF).