Novadip's NVDX3 Stem-Cell Bone Graft Shows Promising Interim Results

At six months post-grafting surgery with NVDX3, x-rays demonstrate that 90% of patients have reached, or are steadily progressing towards, complete bone healing. Derived from Novadip’s 3M3 stem cell platform, NVDX3, a unique 'off-the-shelf' allogeneic matrix product to cure common but challenging orthopedic conditions, has potential to replace existing allogeneic bone substitutes to heal fractures.

MONT SAINT-GUIBERT, Belgium, October 17, 2024 – Novadip Biosciences, a clinical-stage biotechnology company specializing in regenerative medicine, has announced promising interim results from its initial human clinical trial, NVDX3-CLN01. This trial is evaluating the safety and effectiveness of NVDX3 in healing distal radius fractures in adults.

Emanating from Novadip’s innovative 3M3 platform, NVDX3 is an allogeneic bone grafting material developed from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). It is engineered as a lyophilized powder to be utilized as an 'off-the-shelf' implant to promote bone formation between two bone segments in various environments.

NVDX3 represents a novel category of regenerative tissue products designed to speed up bone healing in a single treatment for patients who have a high risk of nonunion due to co-morbidities like aging, diabetes, obesity, smoking, and medication use.

NVDX3-CLN01 (NCT05987033) is a single-arm, open-label clinical trial aimed at evaluating the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, which involve the wrist joint with multiple bone fragments. Ten participants, aged between 28 and 84 years, have been treated in this trial.

Radiological assessments show that 90% of the patients have achieved, or are on the path to achieving, complete bone healing. All but one patient are progressing as expected clinically. The efficacy of NVDX3 appears consistent regardless of age or sex, despite the complexity of the fractures treated. No safety concerns have been noted in this study.

"The interim results of this first clinical trial reflect the safety and efficacy of NVDX3 demonstrated in our nonclinical program. NVDX3 is the first and only bone graft product following a Biologics License Application (BLA) pathway. Based on these preliminary data, NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to co-morbidity factors, experience delayed bone formation or nonunion,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences. “We will share the results of this trauma study with the US FDA as part of our IND submission to support the further clinical development of NVDX3 as we explore its potential for the treatment of complex cervical spine fusion.”

Dr. Philipp Leucht, Vice Chair of Research at the Department of Orthopedic Surgery, NYU Grossman School of Medicine, added, "We need more options to improve outcomes in bone healing, particularly for patients with co-morbidities like advanced age, diabetes, and smoking. These interim results suggest that NVDX3 may have the potential to address this unmet need.”

The 12-month results of NVDX3-CLN01 are anticipated by the end of 2024.

Alongside NVDX3-CLN01, Novadip is also investigating the safety and preliminary efficacy of NVDX3 for achieving spine fusion in the lumbar spine in the NVDX3-CL02 trial (NCT05961956). One-year results from this trial are expected by March 2025.

In addition to the allogeneic program with NVDX3, the company’s lead autologous program, NVD003, is soon entering phase 3 for treating congenital pseudarthrosis of the tibia, a rare pediatric condition often leading to amputation. Planning for a pivotal phase 3 trial and BLA submission is currently underway.