Results from Novadip phase 1b/2a trial reveal 88% efficacy
Natalia Elliot | January 28, 2025 | News story | Clinical Research | Congenital Pseudoarthritis of the Tibia, Rare Diseases, clinical trials, efficacy, paediatric, rare diseases
Novadip Biosciences, a clinical stage biotechnology company with a specialty in regenerative medicine, has announced the results of its 12-month post-surgical visit as part of phase 1b/2a of the NCT05693558 trial.
The trial is to monitor the results of an investigational tissue regeneration product from Novadip, NVD003. The product is derived from adipose stem cells (ACS) as part of an autologous therapy. The treatment is a potential single treatment to save limbs and increase or restore mobility in patients with Congenital Pseudoarthritis of the Tibia (CPT), a rare paediatric bone condition.
Professor PhD and MD Pierre-Louis Docquier stated: “I am very pleased with the results I’ve seen in the children I have treated with NVD003. For orthopedic surgeons, CPT fractures are among the most difficult to treat due to the underlying pathophysiology of the condition.” Professor Docquier is the EU principal investigator for the study and a specialist in paediatric surgery at the University Hospital Saint-Luc in Brussels, Belgium.
The results of the trial were combined with those from four other children previously treated with NVD003 in compassionate use programmes in Belgium, resulting in an 88% efficacy rate for NVD003. 88% of children total, most of whom had previously undergone surgeries which were unsuccessful, achieved healing of their fractures.
Novadip Biosciences is currently selecting sites for phase 3 pivotal trial in CPT. The company plans to begin enrolment for the trial in the second quarter of 2025.
Natalia Elliot
28/1/25
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