The trial intends to recruit a total of four CPT patients from both the US and the EU.
Novadip Biosciences has achieved the first implantation of its investigational tissue regeneration product NVD-003 in its Phase Ib/IIa US/EU clinical trial for the treatment of patients with congenital pseudarthrosis of the tibia (CPT).
The first patient received the implantation by Dr Pierre-Louis Docquier, the European Union (EU) principal investigator for this study, at the Saint-Luc University Hospital in Brussels, Belgium.
The trial aims to recruit four CPT patients aged between two and eight years in the US and EU.
Docquier said: “The potential for this approach to accelerate healthy bone formation, restore mobility and avoid the need for amputation in patients with CPT is tremendous.”
The company revealed that the second patient will receive NVD-003 implantation in June this year. It also plans to begin a pivotal trial in the second half of next year.
Short-term safety of NVD-003 up to 12 months after grafting surgery (GS) is the primary endpoint of the trial.
Assessment of long-term safety, bone formation, tibial length, bone remodelling and bone union at time intervals of three, six, 12 and 24 months after GS are the secondary endpoints.
Novadip Biosciences CEO and founder Dr Denis Dufrane said: “We are excited by the progress in patient recruitment and treatment to date and look forward to assessing clinical and patient outcomes at near and longer-time intervals post-implantation.”
In December last year, the company revealed positive findings from a Phase I/II clinical study of NVD-003 in individuals with severe bone non-union of the lower limb resulting from trauma. The trial was conducted to assess the safety and clinical effectiveness of the product.
The findings revealed the capacity of NVD-003 to reverse severe bone deterioration and attain accelerated ossification.
