Bone seeks to amend study protocol for ALLOB approval

Belgian biotech Bone Therapeutics (Euronext Brussels and Paris: BOTHE) has announced changes to the statistical analysis and the implementation of an interim analysis for the ongoing Phase IIb trial of its allogeneic bone cell therapy product, ALLOB.

Bone will now submit the amendments to the study protocol for approval to the regulatory authorities.

" ...more precisely document the potential benefit of ALLOB over standard practice alone"The company has administered ALLOB in around 60 patients in Phase I and I/IIa trials. The results so far have demonstrated both good tolerability, evidence of increased bone formation and other clinical benefits. Based on these promising initial results, Bone is conducting an additional controlled Phase IIb study in tibial fractures at risk for delayed or non-union.