Overview:
Initial test, a single-arm, open-label 1st-in-human proof-of-concept study in adults with distal radius fractures.
A novel adipose tissue derived bone graft, tentatively named NVDX3, has performed well in its initial test, a single-arm, open-label first-in-human proof-of-concept study in adults with distal radius fractures.
NVDX3 is a three-dimensional (3D) osteogenic graft derived from autologous adipose derived mesenchymal stem cells (ASCs) combined with hydroxyapatite/beta-tricalcium phosphate (HA/TCP) particles.
The novel compound was specifically developed to improve bone healing in severe pathophysiological conditions (e.g., hypoxia, lack of mineralized callus formation, bone resorption and low osteogenicity) as found in congenital pseudoarthrosis, bone tumors (after an extensive surgical resection), osteolytic syndromes like Gorham-Stout disease, genetic bone resorption syndromes with osteoporosis as found in Hajdu-Cheney syndrome and following severe trauma (casualties of war).
The company bringing this material through testing and beyond is Belgium-basedNovadip Biosciences.
NVDX3 Formulation
Formulated as a lyophilized powder, NVDX3 is intended to be used as an “off-the-shelf” implant to induce bone formation between two bone segments and, according to Novadip, is “a new class of regenerative tissue products that accelerate bone healing in a single treatment for patients at high risk of nonunion due to comorbidities (aging, diabetes, obesity, smoking and other conditions) and medication use.”
Study Methodology and Conclusions
This proof-of-concept trial focused on adults with distal radius fractures involving the wrist joint with multiple bone fragments. At the 12-month follow-up visit, the researchers report that 100% of patients experienced bone union of their fractures, regardless of age and complexity of fractures treated (most patients achieved this by the six-month visit). The investigators found no adverse events related to NVDX3.
“I’m very excited by these results, as they strongly indicate that NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to comorbidity factors (e.g., smoking, age), experience delayed bone formation, or nonunion. Currently, no on-label osteobiologic can prevent or cure bone nonunion (up to 30%). With NVDX3, we are addressing a potential market of up to $12B,” said Denis Dufrane, M.D., Ph.D., Novadip Biosciences CEO.
Regarding the development process, Dr. Dufrane told to OTW, “The first preclinical results obtained in the sheep animal model demonstrated the efficacy of NVDX3 in terms of histology, biomechanics and imagery with a high rate of bone fusion. Other milestones were when the first batch of NVDX3 was manufactured from European and U.S. citizens for our clinical trials and when the first patient was implanted with this unique allogenic cell-derived product.”
“NVDX3 is the only physiological osteobiologic that promotes osteoinduction and modulates the bone resorption for an optimal and irreversible bone remodeling, especially in patients with co-morbidities factors as aging and osteoporosis. NVDX3 has one formulation that has multiple handlings and clinical applications including direct implantation in a bone defect after a fracture, in cage for intervertebral spine fusion and for a bridge with a poster-lateral spine fusion or injectable. NVDX3 is fully safe without heterotypic ossification and no inflammatory reactions.”
Going forward, said Dr. Dufrane to OTW, “NVDX3 is heading into a Phase 2b/3 trial in a large cohort of patients for multiple cervical spine fusion, which has a higher risk of non-union.”
