Bone Therapeutics reported that all patients enrolled in the Phase I/IIA study of ALLOB® allogeneic bone cell therapy met the primary endpoint of statistically significant clinical and radiological improvements in the treatment of delayed-union fractures.
At six months following one percutaneous dose of ALLOB to the fracture site, the 21 patients achieved an increase of at least two points on the radiological Tomographic Union Score or an improvement of at least 25% of the clinical Global Disease Evaluation score vs. baseline. Pain at the fracture site, a secondary endpoint, was also reduced by an average of 61%.
The company’s next priority is submitting an application for a Phase IIB trial in delayed-union fractures. The multi-center, randomized, controlled study is expected to begin in 2H19.
In announcing the study results, Bone Therapeutics noted it optimized ALLOB’s production process in order to improve the consistency, scalability and cost-effectiveness to manufacture and ship the product. The company plans to implement the manufacturing process during the Phase IIB trial.
Sources: Bone Therapeutics SA; ORTHOWORLD Inc.