Bone Biologics to Begin Study of NB1 Bone Graft

Bone Biologics received approval to commence a multicenter pilot clinical trial to evaluate the company’s NB1 bone graft in Australia.

This pilot study will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD).

NELL-1 is a recombinant human protein that Bone Biologics licensed through a technology transfer agreement with the UCLA Technology Development Group for worldwide applications. NELL-1 combined with demineralized bone matrix (DBM) forms the product candidate NB1. Bone Biologics has entered into an agreement with MTF Biologics for supplying DBM as a carrier in NB1. NELL-1 has properties that suggest it may be ideal in treating spinal fusion, trauma, osteoporosis and other bone-related indications, and may be especially useful among “hard healers.” This potential lies in its ability to provide rapid, specific and guided control over bone regeneration.

For the NB1 bone graft device, the inclusion of rhNELL-1 provides an ancillary osteopromotive effect that is expected to increase both the quantity and maturity of bone and to increase the rate of spinal fusion. The proposed mechanism of action for rhNELL-1 to improve bone formation is based on published research and involves receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation.

“We are delighted to announce this important step toward beginning our pilot study in humans and look forward to demonstrating the ability of NB1 to support the same or better fusion success rates in hard healers that was generated in our animal studies,” said Jeffrey Frelick, Bone Biologics’ President and Chief Executive Officer.

Source: Bone Biologics