Novadip Biosciences has announced encouraging new data for NVDX3, its allogenic bone grafting product derived from adipose tissue-derived stem cells, reporting strong early results in both preclinical and clinical settings.

In an ovine posterolateral fusion (PLF) model — regarded as a highly translatable model for human spinal procedures — Novadip’s NVDX3 demonstrated early bone formation by 12 weeks and functional fusion by 26 weeks. According to the company, 88% of animals treated with NVDX3 exhibited moderate to complete fusion by week 12, compared with lower fusion rates in autograft controls. By 26 weeks, both NVDX3 and autograft groups achieved near-identical complete fusion rates on palpation (83% and 89%, respectively) and on microCT.

Histopathological evaluation and biomechanical testing further confirmed that NVDX3 promoted effective biological integration and progressive bone remodeling, Novadip stated.

“In this model, an autologous bone graft is the most challenging control one could choose to try and demonstrate a similar or higher rate of spine fusion,” said Dr Jeremiah Easley, associate professor at Colorado State University.

“I wasn’t expecting a product without osteogenic capacity to perform as well as an autologous graft with active cells.”

Early human data appear to support these findings. Interim 12-month results from a phase 1b/2a clinical trial (NVDX3-CLN02, NCT05961956) in five adults undergoing single-level lumbar spine fusion surgery showed no NVDX3-related adverse events and early signs of bone fusion. Patients in the study — aged 57 to 74 and treated using a transforaminal interbody fusion (TLIF) approach — also experienced reductions in pain.

“Together with the previously reported results from the first-in-human trial in traumatic fractures, the safety profile of NVDX3 is looking promising,” said Dr Judy Ashworth, Chief Medical Officer at Novadip.

“A clean safety profile is particularly critical in spine surgery. Having an efficacious product in a single formulation that is safe for use across all types of spine fusion procedures has the potential to be a real gamechanger.”

The company’s CEO, Dr. Denis Dufrane, added that throughout NVDX3’s development, no signs of immunogenicity or ectopic bone formation have been observed.

“Given the good safety and efficacy NVDX3 demonstrated in the ovine PFL model, which is a very challenging model to test the safety of an allogenic product, I’m not surprised to see such a good safety profile in humans,” he said.

Novadip previously reported 12-month safety and preliminary efficacy results from a separate phase 1 study (NVDX3-CL01, NCT05987033) investigating the product as a bone graft for distal radius fractures, with what it described as “excellent” outcomes.

Following an Investigational New Drug (IND) clearance for NVDX3 in November 2024, Novadip is preparing to launch a phase 2b/3 clinical trial for cervical spine fusion in the U.S., with patient recruitment expected to begin in November 2025.

NVDX3, developed using Novadip’s proprietary 3M³ tissue regeneration platform, is formulated as a lyophilized powder for use as an ‘off-the-shelf’ bone grafting implant. It is intended to address bone healing challenges in patients with comorbidities such as ageing, diabetes, obesity, and smoking, and those using medications that impair bone regeneration.

The company, based in Mont Saint-Guibert, Belgium, was founded on research conducted at UCLouvain and St. Luc University Hospital.