Novadip’s NVDX3 Reaches Key Milestones to Start Phase 2B/3 Study

Novadip Biosciences, a clinical-stage biotechnology company specializing in regenerative medicine, received approval from the US Food and Drug Administration (FDA) for its allogenic bone grafting material NVDX3 to enter an investigational new drug study (IND).

The FDA-approved IND study is a phase 2b/3 trial assessing the efficacy of NVDX3 compared to standard-of-care treatments in level two cervical spine fusion.

NVDX3 is an allogenic bone grafting material forming 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. 

The osteogenic properties of NVDX3 make it uniquely suited to compromised bone environments in patients with a risk of fusion failure or settings with decreased bone healing capacity. Therefore, it has the potential to provide higher healing success rates than current treatments (as demonstrated in previous animal and human studies).

The Phase 2b/3 trial aims to enroll 106 participants across up to ten sites in the US. The participants for the study will have symptomatic cervical disc disease and be candidates for spinal fusion at two adjacent levels. 

Patients will be randomized to receive either NVDX3 or a standard-of-care bone graft material and will not be excluded based on comorbidities.

“We are thrilled to have received FDA approval for an IND trial for NVDX3 in spinal fusion. Our robust clinical data behind NVDX3 demonstrates its potential to replace the allogenic bone grafts currently in use, decreasing the risk of disease transmission, reactions due to histocompatibility, and delayed union or fusion in patients at high risk of nonunion. The trial will accelerate our capability to bring NVDX3 to patients with complex needs, providing them with a better chance of healing compared to standard-of-care treatments. These strategic steps enable us to take NVDX3 to the next level,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences.

Recent six-month results from a phase 1b/2a proof-of-concept single-arm clinical trial in lumbar intervertebral spine fusion on one level found that there was an improvement in function compared with pre-surgery status, as measured with the Oswestry Disability Index. 

CT scans at the four-month mark showed progression toward bone union as appropriate for this stage. The trial was carried out on five adult patients aged 57-74 at a single site in Europe, where all participants received NVDX3.

This phase 2b/3 trial is designed with an interim analysis to allow for a seamless conversion into phase 3, thus accelerating its path to market.