Novadip’s trial data reinforces confidence in NVD003 in a move forward with phase 3 trial

Novadip Biosciences, a clinical stage biotechnology company specializing in regenerative medicine, Tuesday said it has completed the 12-month post-surgical visit of the last patient implanted with its investigational tissue regeneration product, NVD003, in the phase 1b/2a clinical trial (NCT05693558).

Four patients with Congenital Pseudarthrosis of the Tibia (CPT), a rare pediatric bone condition, were treated. Novadip is developing NVD003, an autologous therapy derived from adipose stem cells (ASC), as a potential single treatment to save limbs and restore mobility in patients with CPT, the company said in a press release.

Combining the 12-month results from this trial together with those from four other children previously treated with NVD003 in two compassionate use programs in Belgium, 88% of patients, most of whom had prior failed surgeries, achieved healing of their fractures with NVD003, the company said.

“I am very pleased with the results I’ve seen in the children I have treated with NVD003,” said Prof. Pierre-Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint-Luc in Brussels (Belgium) and EU principal investigator for this study. “For orthopedic surgeons, CPT fractures are among the most difficult to treat due to the underlying pathophysiology of the condition.”

At the end of 2022, Novadip announced positive data from a phase 1/2 clinical trial evaluating the safety and clinical activity of NVD003 in adult patients with severe Bone Non-Union (BNU) of the lower limb following trauma. In this trial, eight of the nine patients with recalcitrant BNU had durable bone healing at 24 months and beyond, the company said.

The two treatment failures (one in CPT and one in BNU) occurred in the setting of post-operative mechanical instability of the fracture, the company said.

“We are excited by these new results in CPT,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences. “We are now one step closer to being able to offer a safer and more efficacious bone graft to children who are at high risk of amputations.”

“This data reinforces our confidence in NVD003 as we push forward with our pivotal phase 3 trial,” said Judy Ashworth, MD, chief medical officer at Novadip Biosciences. “Pediatric surgeons desperately need more treatment options for children.”

The company is selecting sites for its phase 3 pivotal trial in CPT with the aim of starting enrollment in Q2, 2025.