Bone Therapeutics announced positive efficacy results for the 2nd patient cohort in its Phase I/IIA trial of ALLOB® allogeneic bone cell therapy product for the treatment of delayed-union fractures. Of eight patients treated, seven met primary endpoints of the trial within 6-month follow-up.
The ongoing Phase I/IIA study is a 6-month open-label trial to evaluate safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones.
This 8-patient cohort yielded radiological scores with a statistically significant improvement (77%) at 6 months. Overall, pain at the fracture site improved by 68% and health status by 50% at 6 months, also statistically significant levels.
Sources: Bone Therapeutics S.A., ORTHOWORLD