Belgium-based biotech company BioSenic has announced that it is suspending the development of its investigational allogeneic cell therapy derived from mesenchymal stem cells, called ALLOB, which was being assessed as a treatment for tibial fractures. The decision to pause ALLOB’s development comes after disappointing results in a Phase IIb trial, which had been designed to evaluate the candidate’s safety and timing efficacy. Data from the study showed that early ALLOB administration failed to speed up the fracture healing process significantly. While the cell therapy candidate missed its primary endpoint in the mid-stage trial, data still show “the excellent safety profile of ALLOB injections, with no reported serious adverse events related to experimental treatment,” according to BioSenic’s Chief Medical Officer Lieven Huysse.
Results from a previous Phase IIa study also showed that when administered three-and-a-half to seven months after a fracture, ALLOB could significantly accelerate healing. Together with its promising pre-clinical performance, these safety and efficacy data suggest that ALLOB “remains of potential benefit as an add-on to the standard of care,” according to BioSenic’s press release.