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Novadip Biosciences reports positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults.
Originating from Novadip’s 3M3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells. It is formulated as a lyophilized powder intended to be used as an off-the-shelf implant to induce bone formation between two bone segments in both orthotopic and heterotopic environments.
NVDX3 is a new class of regenerative tissue products that accelerates bone healing in a single treatment for patients at high risk of nonunion due to co-morbidities and medication use.
NVDX3-CLN01 is a single-arm, open-label clinical trial designed to assess the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, involving the wrist joint with multiple bone fragments. Ten participants, aged 28 to 84 years old, were treated.
Radiologically, 90% of patients have achieved, or are on track to achieve, complete bone healing. All but one are progressing as expected clinically. There is no apparent impact of age or sex on the efficacy of NVDX3, despite the complexity of fractures treated. There have also been no safety concerns arising from this study.
Twelve-month results of NVDX3-CLN01 are expected at the end of 2024.
“The interim results of this first clinical trial mirror 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.”
In parallel to NVDX3-CLN01, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in trial NVDX3-CL02. One-year results from this trial are expected in March 2025.
In addition to its allogeneic program with NVDX3, the clinical development of the company’s lead autologous program, NVD003, will soon be entering phase 3 for the treatment of congenital pseudarthrosis of the tibia, a rare pediatric disease that often leads to amputation. Planning for a pivotal phase 3 trial and BLA submission is underway.
Source: Novadip Biosciences
Novadip Biosciences reports positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults.
Originating from Novadip’s 3M3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal...
Novadip Biosciences reports positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults.
Originating from Novadip’s 3M3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells. It is formulated as a lyophilized powder intended to be used as an off-the-shelf implant to induce bone formation between two bone segments in both orthotopic and heterotopic environments.
NVDX3 is a new class of regenerative tissue products that accelerates bone healing in a single treatment for patients at high risk of nonunion due to co-morbidities and medication use.
NVDX3-CLN01 is a single-arm, open-label clinical trial designed to assess the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, involving the wrist joint with multiple bone fragments. Ten participants, aged 28 to 84 years old, were treated.
Radiologically, 90% of patients have achieved, or are on track to achieve, complete bone healing. All but one are progressing as expected clinically. There is no apparent impact of age or sex on the efficacy of NVDX3, despite the complexity of fractures treated. There have also been no safety concerns arising from this study.
Twelve-month results of NVDX3-CLN01 are expected at the end of 2024.
“The interim results of this first clinical trial mirror 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.”
In parallel to NVDX3-CLN01, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in trial NVDX3-CL02. One-year results from this trial are expected in March 2025.
In addition to its allogeneic program with NVDX3, the clinical development of the company’s lead autologous program, NVD003, will soon be entering phase 3 for the treatment of congenital pseudarthrosis of the tibia, a rare pediatric disease that often leads to amputation. Planning for a pivotal phase 3 trial and BLA submission is underway.
Source: Novadip Biosciences
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
