Novadip Biosciences’s bone grafting material NVDX3 has seen all patients achieve bone fracture union in a 12-month Phase Ib/IIa proof-of-concept study.
The Belgian company’s NVDX3-CLN01 (NCT05987033) first-in-human trial examined the company’s allogeneic material, created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs) in ten patients with wrist fractures.
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The trial enrolled patients aged between 28 and 84 years old who were treated with NVDX3. At the 12-month follow-up visit, 100% of patients had a bone union of their fractures, but most had already achieved this by the six-month visit. No adverse events (AEs) observed in the trial were deemed to be related to NVDX3.
NVDX3 is Novadip’s bone graft comes in the form of a freeze-dried powder intended as an off-the-shelf implant to induce bone formation between two bone segments. The company now intends to launch a Phase IIb/III trial in two-level cervical spine fusion, set to begin in November 2025.
Novadip CEO Denis Dufrane said: “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, experience delayed bone formation or non-union. Currently, no on-label osteobiologic can prevent or cure bone non-union up to 30%.”
At the same time, the company is awaiting results from a parallel trial investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in its NVDX3-CL02 (NCT05961956) trial, with 12-month results expected next month.
Research by GlobalData estimates that the overall international bone graft and substitutes market brought in sales of $3.2bn in 2024, with that figure expected to remain relatively steady, bringing in $3.9bn by the end of 2030. Of that, allograft bone chips are set to make up $1bn.
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Philipp Leucht, vice chair of research at the New York University Grossman School of Medicine, said: “I’m looking forward to seeing how NVDX3 performs in larger, randomized clinical trials compared with standard-of-care bone graft materials. Surgeons urgently need more effective options, especially for patients with comorbidities that can negatively impact bone healing.”
As well as its allogeneic programme with NVDX3, Novodip’s lead autologous therapy, NVD003, is set to enter a Phase III trial as a potential treatment for congenital pseudarthrosis of the tibia, a rare paediatric condition often leading to amputation.
Elsewhere in the field of bone grafts and substitutes, SurGenTec has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoFlo HydroFiber, a synthetic material for use in spinal surgery. Meanwhile, RevBio has received approval from the FDA to expand an ongoing clinical trial of its bone adhesive biomaterial Tetranite.
