A novel cell-based bone graft, one that is going through the rigorous FDA Biologic License Application (BLA) process, has reached an important milestone in its first in-human clinical trials.
The new product, NVDX3-CLN01, developed by Belgium-based NOVADIP Biosciences S.A., is a cell-based bone substitute for fracture healing indications. The company recently released interim results from its first-in-human clinical trial and reported that, at six months post-grafting surgery with NVDX3, S-rays demonstrated that 90% of patients reached or are steadily progressing towards complete bone healing.
“NVDX3 is an allogeneic cell-derived product made of mineral particles with a neo-synthetized matrix containing growth factors and miRNA involved in the bone healing,” Denis Dufrane, M.D., Ph.D., company CEO told OTW.
“NVDX3 is derived from our 3-dimensional cell-based platform with adipose stem cells. Indeed, our platform already demonstrated its safety and efficacy with the autologous bone product NVD003, a first-in-class product dedicated to the treatment of critical size bone defects and to avoid amputation.”
According to the company, 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 (aging, diabetes, obesity, smoking, and other conditions) and medication use. Ten participants, aged 28 to 84 years old, were treated.
According to the company, all but one are progressing as expected clinically and factors such as age or sex did not have a statistically significant effect on outcomes. The company also reported that there were no safety concerns arising from their study.
OTW asked Dr. Dufrane to provide details regarding the lyophilized powder and he said, “NVDX3 is a bioactive powder with less than 5% of residual moisture for preservation at room temperature in the operating room; it is available 7/24 for the surgeon.”
“The Biologics License Application is the regulatory pathway to demonstrate the safety and the efficacy of a drug. NVDX3 is the first and the only product to follow the Biologics License Application pathway in the orthopedic field to demonstrate its pharmacological activity and restore bone physiology.”
The 12-month results of NVDX3-CLN01 are expected at the end of 2024. Going forward, says the company, the first Phase 2b will focus on multilevel cervical spine fusion. —
