(Boursier.com) — Bone Therapeutics today announces the optimization of the statistical analysis and the inclusion of an interim analysis in the Phase IIb clinical trial evaluating its allogeneic cell therapy product, ALLOB. Bone Therapeutics will promptly submit amendments to the study protocol for regulatory approval after consultation with current and potential partners.
Bone Therapeutics has administered ALLOB to approximately 60 patients in multiple Phase I and I/IIa clinical trials. Clinical results to date have demonstrated both good tolerability, evidence of increased bone formation and other clinical benefits. Based on these promising initial results, Bone Therapeutics is currently conducting an additional controlled phase IIb study in tibial fractures at risk of delayed union or non-union.
Recently published medical data has provided new information on the impact on duration and dynamics of certain radiological evidence on fracture resolution. Based on these new data, Bone Therapeutics has improved the statistical analysis of the Phase IIb study evaluating ALLOB. The updated analysis will provide an optimal radiological assessment of the acceleration of bone formation 3 months after intra-fracture administration of ALLOB, compared to the reference standard procedure. The updated statistical analysis converts one of the current secondary endpoints to a primary endpoint and will therefore have limited impact on the conduct of the study. This protocol update will also reduce the number of patients required by approximately 20%, from 178 patients to 132 evaluable patients, while maintaining the same statistical power.
In addition, this updated analysis should help define the goals and endpoints of fracture healing in subsequent studies, namely the planned Phase III confirmatory study for fractures as well as the bone regeneration studies. in other clinical indications.
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